acurio AS-301
by Xiamen Acurio Instrument Co., Ltd
acurio AS-301 is a Class II device made by Xiamen Acurio Instrument Co., Ltd, cleared under FDA 510(k) K180685 on 29 Nov 2018 and listed in FDA GUDID since 30 Jun 2020 (UDI-DI 06972382160211), 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 | Number06972382160211 | Date30 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180685 | Date29 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 06972382160211
- FDA 510(k) database K180685
Across registries
- FDA 510(k) K180685 decided 29 Nov 2018 Active
- FDA GUDID UDI-DI 06972382160211 listed 30 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K180685
- Listed FDA GUDID 06972382160211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- acurio
- Generic name
- Pulse oximeter
- Model / reference
- AS-301
- Primary DI / UDI-DI
- 06972382160211
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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