MRIaudioPREM1002
by Mriaudio
MRIaudioPREM1002 is a Class II device made by Mriaudio, cleared under FDA 510(k) K180100 on 14 Jun 2018 and listed in FDA GUDID since 5 Oct 2018 (UDI-DI B66910021), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB66910021 | Date5 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180100 | Date14 Jun 2018 | StatusActive |
Official records
- FDA 510(k) database K180100
Across registries
- FDA 510(k) K180100 decided 14 Jun 2018 Active
- FDA GUDID UDI-DI B66910021 listed 5 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K180100
- Listed FDA GUDID B66910021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Patient audiovisual communication/entertainment system
- Model / Ref / Catalog
- 1002
- Primary DI / UDI-DI
- B66910021
- 510(k) Number
- 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
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