Sterimed A0307

• FDA 510(k) K853044 decided 1 Nov 1985 Active
• FDA GUDID UDI-DI 00850341007950 listed 13 Dec 2016 Listed

1. 1 Nov 1985 Cleared FDA 510(k) K853044
2. 13 Dec 2016 Listed FDA GUDID 00850341007950

Trade name

Sterimed

Generic name

X-ray system cover

Model / reference

A0307

Primary DI / UDI-DI

00850341007950

510(k) Number

K853044 ↗

FDA product code

IZI

GMDN term

X-ray system cover

Device class

Class II

Regulation number

892.1600

GUDID distribution status

In Commercial Distribution

Category: X-ray system cover

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• Sterimed 4425B

  Class II

  FDA 510(k) K853044 Active Cleared 1 Nov 1985 GUDID on market

• Arjo Wiggins Medical, Inc. 1011001212D

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  FDA 510(k) K931202 Active Cleared 16 Dec 1993 GUDID on market

• Sterimed PC0796

  Class II

  FDA 510(k) K853044 Active Cleared 1 Nov 1985 GUDID on market

• Arjo Wiggins Medical, Inc. 1010882828

  Class II

  FDA 510(k) K931202 Active Cleared 16 Dec 1993 GUDID on market

See all devices from Sterimed, Inc. →