QScreen Set 101275-A-IP
QScreen Set 101275-A-IP is a Class II device made by PATH medical GmbH, cleared under FDA 510(k) K220139 on 3 Aug 2022 and listed in FDA GUDID since 19 May 2023 (UDI-DI 04260223146275), 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 | Number04260223146275 | Date19 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220139 | Date3 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 04260223146275
- FDA 510(k) database K220139
Across registries
- FDA 510(k) K220139 decided 3 Aug 2022 Active
- FDA GUDID UDI-DI 04260223146275 listed 19 May 2023 Listed
Timeline
- Cleared FDA 510(k) K220139
- Listed FDA GUDID 04260223146275
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QScreen Set
- Generic name
- Evoked-potential audiometer
- Model / reference
- 101275-A-IP
- Primary DI / UDI-DI
- 04260223146275
- 510(k) Number
- FDA product code
- GWJ
- GMDN term
- Evoked-potential audiometer
- Device class
- Class II
- Regulation number
- 882.1900
- GUDID distribution status
- In Commercial Distribution
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