Ultrasonic Pocket Doppler
20 catalogue numbers from SD3 LITE, listed by Edan Instruments, Inc., China, under Monitor, Ultrasonic, Fetal. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
20catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (10), Beijing (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Shenzhen Yuezhongxing Technology Co., Ltd. | Huizhou | Guangdong | Repacker / relabeller | 10 |
| Shenzhen Jumper Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Shenzhen Imdk Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Zhongshan Xiaolan Town Senlan Electronic Factory | Zhongshan | Guangdong | Manufacturer | 4 |
| Shenzhen Jamr Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Ninghai Guangjie Electronic Commerce Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 3 |
| Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Shenzhen Taikang Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Shenzhen Bestman Instrument Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Monitor, Ultrasonic, Fetal
Record
| Listed by | Edan Instruments, Inc., China |
|---|---|
| FDA product code | KNG |
| Device type | Monitor, Ultrasonic, Fetal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2660 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K140579 |
| Record published | 2016-09-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 10, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD3 LITE | In distribution | |
| PD-100B | In distribution | |
| SD3 | In distribution | |
| PD-1000 Plus | In distribution | |
| SD3 PLUS | In distribution | |
| SONOTRAX Basic A | In distribution | |
| SONOTRAX Pro | In distribution | |
| SONOTRAX Ⅱ Pro | In distribution | |
| PD-100 Plus | In distribution | |
| PD-100A | In distribution | |
| PD-1000 | In distribution | |
| PD-100 Pro | In distribution | |
| SD3 Vascular | In distribution | |
| SD1 | In distribution | |
| SD3 PRO | In distribution | |
| SONOTRAX Ⅱ | In distribution | |
| PD-1000 Pro | In distribution | |
| SONOTRAX Vascular | In distribution | |
| SONOTRAX Lite | In distribution | |
| SONOTRAX Basic | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dopplex | Huntleigh Healthcare Ltd. | 30 |
| Vcomin Fetal Doppler | Vcomin Technlogy Limited | 27 |
| Summit Doppler | Coopersurgical, Inc. | 25 |
| MediChoice | Coopersurgical, Inc. | 21 |
| McKesson | Mckesson Medical-Surgical Inc. | 18 |
| ClearTone Doppler | Coopersurgical, Inc. | 16 |
| fetal doppler | Shenzhen Jumper Medical Equipment Co., Ltd. | 11 |
| Contec | Contec Medical Systems Co., Ltd. | 10 |
| Monitor, Ultrasonic, Fetal | Edan Instruments, Inc. | 6 |
| FaceLake | Lorte Technologies, Inc | 6 |
| Natus Neurology | Natus Neurology Incorporated | 5 |
| Ultrasonic TableTop Doppler | Edan Instruments, Inc. | 4 |
Showing 12 of 69. All products under Monitor, Ultrasonic, Fetal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172780 | 2018-06-06 |
| K153475 | 2016-01-29 |
| K140579 | 2015-02-06 |
| K092997 | 2009-11-10 |
| K080087 | 2008-03-11 |
| K040480 | 2004-05-25 |
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.