Iob Iob-301

• FDA 510(k) K190221 decided 25 Oct 2019 Active
• FDA GUDID UDI-DI 00850035767993 listed 8 Mar 2022 Listed

1. 25 Oct 2019 Cleared FDA 510(k) K190221
2. 8 Mar 2022 Listed FDA GUDID 00850035767993

Trade name

Iob

Generic name

Circulating-air whole-body heating system control unit

Model / reference

IOB-301

Primary DI / UDI-DI

00850035767993

510(k) Number

K190221 ↗

FDA product code

DWJ

GMDN term

Circulating-air whole-body heating system control unit

Device class

Class II

Regulation number

870.5900

GUDID distribution status

In Commercial Distribution

Category: Circulating-air whole-body heating system control unit

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• IOB Warming Blankets

  Class II

  FDA 510(k) K221669 Active Cleared 27 Dec 2022

• Iob Iob-006

  Class II

  FDA 510(k) K162679 Active Cleared 28 Apr 2017 GUDID on market

• Iob Iob-016

  Class II

  FDA 510(k) K162679 Active Cleared 28 Apr 2017 GUDID on market

• Iob Iob-304

  Class II

  FDA 510(k) K190221 Active Cleared 25 Oct 2019 GUDID on market

See all devices from Iob Medical, Inc. →