Bci WW1018G
Bci WW1018G is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K083557 on 1 May 2009 (2 earlier submissions) and listed in FDA GUDID since 13 Jan 2020 (UDI-DI 10610586039652), 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 | Number10610586039652 | Date13 Jan 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083557 | Date1 May 2009 | StatusActive |
Official records
- AccessGUDID record 10610586039652
- FDA 510(k) database K083557
- FDA 510(k) database K083787
- FDA 510(k) database K083705
Across registries
- FDA 510(k) K083557 decided 1 May 2009 Active
- FDA GUDID UDI-DI 10610586039652 listed 13 Jan 2020 Listed
Timeline
- Cleared FDA 510(k) K083705
- Cleared FDA 510(k) K083787
- Cleared FDA 510(k) K083557
- Listed FDA GUDID 10610586039652
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bci
- Generic name
- Pulse oximeter, line-powered
- Model / reference
- WW1018G
- Primary DI / UDI-DI
- 10610586039652
- FDA product code
- DQA, DPZ
- GMDN term
- Pulse oximeter, line-powered
- Device class
- Class II
- Regulation number
- 870.2700, 870.2710
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Pulse oximeter, line-powered.