Apk S543-490
Apk S543-490 is a Class II device made by Apk Technology, cleared under FDA 510(k) K082846 on 3 Apr 2009 and listed in FDA GUDID since 6 May 2022 (UDI-DI 06946725536414), active as of 22 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 | Number06946725536414 | Date6 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082846 | Date3 Apr 2009 | StatusActive |
Official records
- AccessGUDID record 06946725536414
- FDA 510(k) database K082846
Across registries
- FDA 510(k) K082846 decided 3 Apr 2009 Active
- FDA GUDID UDI-DI 06946725536414 listed 6 May 2022 Listed
Timeline
- Cleared FDA 510(k) K082846
- Listed FDA GUDID 06946725536414
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Apk
- Generic name
- Pulse oximeter probe, single-use
- Model / reference
- S543-490
- Primary DI / UDI-DI
- 06946725536414
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter probe, single-use
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
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