Apk A1411-SI02C
Apk A1411-SI02C is a Class II device made by APK Technology Co., Ltd., cleared under FDA 510(k) K172981 on 8 Jun 2018 and listed in FDA GUDID since 22 Sep 2025 (UDI-DI 06946725504253), active as of 12 Nov 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 | Number06946725504253 | Date22 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172981 | Date8 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 06946725504253
- FDA 510(k) database K172981
Across registries
- FDA 510(k) K172981 decided 8 Jun 2018 Active
- FDA GUDID UDI-DI 06946725504253 listed 22 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K172981
- Listed FDA GUDID 06946725504253
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- Withdrawn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
- A1411-SI02C
- Primary DI / UDI-DI
- 06946725504253
- 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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