VitaloJAK 7100

• FDA 510(k) K110525 decided 23 Nov 2011 Active
• FDA GUDID UDI-DI 15099169715100 listed 17 May 2018 Listed

1. 23 Nov 2011 Cleared FDA 510(k) K110525
2. 17 May 2018 Listed FDA GUDID 15099169715100

Trade name

VitaloJAK

Generic name

Cough ambulatory recording system

Model / reference

7100

Primary DI / UDI-DI

15099169715100

510(k) Number

K110525 ↗

FDA product code

DSH

GMDN term

Cough ambulatory recording system

Device class

Class II

Regulation number

870.2800

GUDID distribution status

In Commercial Distribution

Category: Cough ambulatory recording system

Other devices filed under FDA product code DSH (RECORDER, MAGNETIC TAPE, MEDICAL).

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• MEDILOG FD4 by Oxford Instruments Medical Systems
• AT-Patch (ATP-C130/ATP-C70) by ATsens Co., Ltd.
• Holta-Med Recorder by Holta-Med
• Multitrak-Plus by Zymed Medical Instrumentation
• Patient Cable 9293-017-51 by MORTARA INSTRUMENT, INC.
• Carnation Ambulatory Monitor by BARDY DIAGNOSTICS, INC.

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See all devices from Vitalograph Ireland, Ltd. →