Nellcor SC-NEO
by Covidien LP
Nellcor SC-NEO is a Class II device made by Covidien LP, cleared under FDA 510(k) K030930 on 23 May 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20884522042434), 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 | Number20884522042434 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030930 | Date23 May 2003 | StatusActive |
Official records
- AccessGUDID record 20884522042434
- FDA 510(k) database K030930
Across registries
- FDA 510(k) K030930 decided 23 May 2003 Active
- FDA GUDID UDI-DI 20884522042434 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K030930
- Listed FDA GUDID 20884522042434
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nellcor
- Generic name
- Pulse oximeter probe, single-use
- Model / reference
- SC-NEO
- Primary DI / UDI-DI
- 20884522042434
- 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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