MRIaudioPREM1004 1005

• FDA 510(k) K180100 decided 14 Jun 2018 Active
• FDA GUDID UDI-DI B66910051 listed 31 Mar 2026 Listed

1. 14 Jun 2018 Cleared FDA 510(k) K180100
2. 31 Mar 2026 Listed FDA GUDID B66910051

Trade name

MRIaudioPREM1004

Generic name

Patient audiovisual communication/entertainment system

Model / Ref / Catalog

1005

Primary DI / UDI-DI

B66910051

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

Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).

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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

• MRIaudio 1507

  Class II

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

See all devices from Mriaudio →