Proscope™

PROSCOPE Pediatric/Infant Scope,Yellow Adimals Pulse Oximeter,Fingertip, Pediatric

Registry build 21.09.26
64manufacturers in China registered for this device type
292catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (26), Jiangsu (13), Shanghai (7). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LDE
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Wenzhou Caretek Medical Device Co., Ltd. Wenzhou Zhejiang Contract manufacturer 30
Jiangsu Yuyue Medical Equipment & Supply Company Limited Jiangsu Jiangsu Contract manufacturer 17
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9
Vapo Healthcare Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Xiantao Junhui Plastic Products Co., Ltd. Xiantao Hubei Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99

Showing 12 of 64. All 64 manufacturers in China registered for Stethoscope, Manual

Record

Regulatory record for Proscope™
Listed by American Diagnostic Corp., United States
FDA product code LDE
Device type Stethoscope, Manual
Device class Class 1
Regulation 21 CFR 870.1875
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2016-10-21
Record revised 2024-11-25 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number
Storage Storage environment humidity 15 to 85 % RH; Storage environment temperature -4 to 131 °F
Packaging Master case of 36, master case of 50, master case of 500, inner pack of 10, master case of 5, master case of 24
Distribution end date 2019-04-11

Catalogue Numbers

Catalogue numbers for Proscope™
Catalogue number Size Per pack Status
675NYQ In distribution
676W 10 In distribution
675TQ In distribution
675W In distribution
676GR In distribution
670BKH 10 In distribution
675LVQ In distribution
670BK In distribution
665RB-10 In distribution
698BKQ 10 In distribution
676NYQ 10 In distribution
675GR In distribution
660GH 10 In distribution
662 In distribution
676R 10 In distribution
675BKH 10 In distribution
660YA In distribution
670MQ In distribution
660BKH 10 In distribution
670BD In distribution
675TQQ In distribution
660RQ In distribution
660-05TW In distribution
670WQ In distribution
660-05TGD In distribution
670Y In distribution
670DGQ In distribution
660-05TBD In distribution
660TLQ In distribution
660M In distribution
675-6Y In distribution
676DGQ In distribution
660FLQ In distribution
670GDQ In distribution
670BKZ In distribution
676VQ 10 In distribution
676-02 In distribution
675BK In distribution
675N In distribution
670TLQ In distribution
660P In distribution
670BDQ In distribution
676V 10 In distribution
660LV In distribution
675BD In distribution
670W In distribution
660FGQ In distribution
676BKQ In distribution
675GRQ In distribution
670RH 10 In distribution
676P 10 In distribution
676GQ In distribution
660RBQ In distribution
660BKQ In distribution
676DG In distribution
660R In distribution
675NOQ In distribution
670TL In distribution
670-04 In distribution
698BK 10 In distribution
660NOQ In distribution
670GRZ In distribution
660GD In distribution
660NQ In distribution
676FLQ In distribution
660-05TR In distribution
662-01 In distribution
665RB In distribution
660-05TNY In distribution
670NP In distribution
675LB In distribution
665Y-10 In distribution
676-03 In distribution
676NPQ In distribution
675V In distribution
660NPQ In distribution
676NOQ In distribution
660GQ In distribution
661-03 In distribution
660-05TY In distribution
675LV In distribution
675LBQ In distribution
676LBA In distribution
670V In distribution
660G In distribution
660-05TLB In distribution
660GR In distribution
664BK In distribution
675MQ In distribution
640BK In distribution
675R In distribution
660-05TNO In distribution
675NQ In distribution
676RQ 10 In distribution
676BKH 10 In distribution
660-05 In distribution
676GDQ In distribution
676NQ 10 In distribution
670P In distribution
676-04G In distribution
662-02 In distribution
675VQ In distribution
670NYQ In distribution
660-05TFG In distribution
660-05TRB In distribution
675FGQ In distribution
670RBH 50 In distribution
660LB In distribution
670GQ In distribution
676RBQ 10 In distribution
660TQQ In distribution
660TL In distribution
660PQ In distribution
660WQ In distribution
665RB-100 In distribution
670NQ In distribution
676N In distribution
676GD In distribution
660BD In distribution
670GR In distribution
670RBA In distribution
660YH 10 In distribution
675DG In distribution
660BDQ In distribution
670RQ In distribution
675RB In distribution
675DGQ In distribution
670LV In distribution
660-05TBR In distribution
676BK In distribution
670BKA In distribution
660BKA In distribution
676BRQ In distribution
675RQ In distribution
670G In distribution
670NPQ In distribution
675Y In distribution
660BK In distribution
675G In distribution
675BKA In distribution
660BRQ In distribution
672-09-01 In distribution
675GA In distribution
660DG In distribution
675PQ In distribution
830-13TBK Thigh, 40-66cm 10 In distribution
660VQ In distribution
662Q In distribution
675NY In distribution
670GH 10 In distribution
675WQ In distribution
675GQ In distribution
676BD In distribution
670GD In distribution
675TLQ In distribution
660-05TTL In distribution
675GD In distribution
675BKQ In distribution
660GDQ In distribution
675BDQ In distribution
660-06 In distribution
670DG In distribution
676BR In distribution
670RB In distribution
671 In distribution
675BRQ In distribution
660LVQ In distribution
665Y In distribution
676G In distribution
660RB In distribution
660YQ In distribution
675NO In distribution
670VQ In distribution
671BKBD In distribution
676Y 10 In distribution
676LV In distribution
664Y In distribution
660-05TLV In distribution
660-05TV In distribution
660RBA In distribution
676NP 10 In distribution
675RBQ In distribution
675P In distribution
660V In distribution
676MQ In distribution
660BKZ In distribution
670LBQ In distribution
676RB 10 In distribution
676YQ 10 In distribution
675NP In distribution
660-05TFL In distribution
670R In distribution
675YQ In distribution
660-05TDG In distribution
670RA In distribution
660GRQ In distribution
676TQQ 10 In distribution
660-05TM In distribution
670M In distribution
675-02 In distribution
670N In distribution
676NO In distribution
676LBQ In distribution
675-04 In distribution
676TL 10 In distribution
670PQ In distribution
660RBH 50 In distribution
670RBQ In distribution
660W In distribution
676PA 10 In distribution
676NY 10 In distribution
675TL In distribution
670GA In distribution
675FLQ In distribution
660RBH 10 In distribution
660NP In distribution
675NPQ In distribution
660-05TNP In distribution
675-03 In distribution
660N In distribution
662-03 In distribution
675GDQ In distribution
672-03 In distribution
660MQ In distribution
676LVQ In distribution
661 In distribution
660Y In distribution
660NO In distribution
665Y-100 In distribution
660DGQ In distribution
660NYQ In distribution
670NOQ In distribution
670LB In distribution
675M In distribution
670GRQ In distribution
660LBQ In distribution
660-05TBK In distribution
671BKTL In distribution
676FGQ In distribution
660GA In distribution
660-05TP In distribution
640BKZ In distribution
676M In distribution
660NY In distribution
670BKQ In distribution
676LB In distribution
670LVQ In distribution
660RA In distribution
670RBH 10 In distribution
671BKRB In distribution

Showing 250 of 292 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Adscope® American Diagnostic Corp. 737
MDF® MDF Instruments Medifriend Inc. 226
Stethoscope Rashman Corp. 185
3M™ Littmann® 3M Company 118
3M™ Littmann® Classic III™ 3M Company 84
Cardinal Health Cardinal Health 200, LLC 79
3M™ Littmann® Cardiology IV™ 3M Company 78
Sklar® Sklar Corporation 55
Welch Allyn, Inc. Welch Allyn, Inc. 53
MediChoice Owens & Minor Distribution, Inc. 48
Labtron GF Health Products, Inc 45
Medline Medline Industries, Inc. 45

Showing 12 of 165. All products under Stethoscope, Manual

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K935944 1994-03-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer