BiDop 7

• FDA 510(k) K201114 decided 5 Jan 2021 Active
• FDA GUDID UDI-DI 00894912002159 listed 20 Jan 2021 Listed

1. 5 Jan 2021 Cleared FDA 510(k) K201114
2. 20 Jan 2021 Listed FDA GUDID 00894912002159

Generic name

Noninvasive vascular ultrasound system

Model / Ref / Catalog

BiDop 7

Primary DI / UDI-DI

00894912002159

510(k) Number

K201114 ↗

FDA product code

DPW

GMDN term

Noninvasive vascular ultrasound system

Device class

Class II

Regulation number

870.2100

GUDID distribution status

In Commercial Distribution

Category: Noninvasive vascular ultrasound system

Other devices filed under FDA product code DPW (Flowmeter, Blood, Cardiovascular).

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• VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger by REMINGTON MEDICAL, INC.
• WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC by Wright Medical
• Ultrasonic Pocket Doppler SD3 PRO by Edan Instruments, Inc.

• BT8M05S8A

  Class II

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• Pg-01

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• VRP Probe VRP-20

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• Hd-307 HD307--8

  Class II

  FDA 510(k) K912409 Active Cleared 23 Dec 1991 GUDID on market

See all devices from Koven Technology, Inc. →