VantageView™

Fiber Input Cable Module, 120V

Registry build 21.09.26
1manufacturer
11catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DXJ
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77

Record

Regulatory record for VantageView™
Listed by St. Jude Medical, United States
FDA product code DXJ
Device type Display, Cathode-Ray Tube, Medical
Device class Class 2
Regulation 21 CFR 870.2450
Establishment Manufacturer, Exporter
510(k) K110085
Record published 2016-03-28
Record revised 2024-05-03 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Storage environment humidity 30 to 75 % RH; Special storage condition: Keep Dry.; Handling environment temperature -20 to 60 °C; Handling environment humidity 30 to 75 % RH; Storage environment temperature -20 to 60 °C

Catalogue Numbers

Catalogue numbers for VantageView™
Catalogue number Size Status
System In distribution
System In distribution
System In distribution
H700470 In distribution
System In distribution
System In distribution
VS100006 In distribution
System In distribution
System In distribution
System In distribution
VS100003 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Excite™ Merit Medical Systems, Inc. 14
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Medline Industries, Inc. Medline Industries, Inc. 7
Barco Barco, Inc 4
Datapad LivaNova Deutschland GmbH 3
IntelliVue GuardianSoftware Philips Medizin Systeme Böblingen GmbH 3
Connect LivaNova Deutschland GmbH 2
Display, Cathode-Ray Tube, Medical Philips Medical Systems Hsg 2

Showing 12 of 24. All products under Display, Cathode-Ray Tube, Medical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K110085 2011-01-26

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