MRIaudioPREM1001

• FDA 510(k) K180100 decided 14 Jun 2018 Active
• FDA GUDID UDI-DI B66910011 listed 5 Oct 2018 Listed

1. 14 Jun 2018 Cleared FDA 510(k) K180100
2. 5 Oct 2018 Listed FDA GUDID B66910011

Generic name

Patient audiovisual communication/entertainment system

Model / Ref / Catalog

1001

Primary DI / UDI-DI

B66910011

510(k) Number

K180100 ↗

FDA product code

LNH

GMDN term

Patient audiovisual communication/entertainment system

Device class

Class II

Regulation number

892.1000

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Patient audiovisual communication/entertainment system

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• MRIaudioPREM1003

  Class II

  FDA 510(k) K180100 Active Cleared 14 Jun 2018 GUDID on market

• MRIaudioPREM1004

  Class II

  FDA 510(k) K180100 Active Cleared 14 Jun 2018 GUDID on market

• 3G Transducer 101

  Class II

  FDA 510(k) K180100 Active Cleared 14 Jun 2018 GUDID on market

• MRIaudioPREM1004 1005

  Class II

  FDA 510(k) K180100 Active Cleared 14 Jun 2018 GUDID on market

See all devices from Mriaudio →