Temp Probe TP-01

• FDA 510(k) K131623 decided 17 Jan 2014 Active
• FDA GUDID UDI-DI 00894912002838 listed 25 Feb 2016 Listed

1. 17 Jan 2014 Cleared FDA 510(k) K131623
2. 25 Feb 2016 Listed FDA GUDID 00894912002838

Trade name

Temp Probe

Generic name

Noninvasive vascular ultrasound system, line-powered

Model / Ref / Catalog

TP-01

Primary DI / UDI-DI

00894912002838

510(k) Number

K131623 ↗

FDA product code

JOP

GMDN term

Noninvasive vascular ultrasound system, line-powered

Device class

Class II

Regulation number

870.2880

GUDID distribution status

In Commercial Distribution

Category: Noninvasive vascular ultrasound system, line-powered

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• Detachable PPG Clip sensor by VIASONIX LTD

• BT8M05S8A

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  FDA 510(k) K934638 Active Cleared 13 May 1994 GUDID on market

• Pg-01

  Class II

  FDA 510(k) K131623 Active Cleared 17 Jan 2014 GUDID on market

• VRP Probe VRP-20

  Class II

  FDA 510(k) K935994 Active Cleared 11 May 1995 GUDID on market

• 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. →