sourcemark SM400TYP
sourcemark SM400TYP is a Class II device made by Sourcemark, LLC., cleared under FDA 510(k) K111282 on 11 Aug 2011 and listed in FDA GUDID since 19 Feb 2019 (UDI-DI 00897392002640), 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 | Number00897392002640 | Date19 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111282 | Date11 Aug 2011 | StatusActive |
Official records
- AccessGUDID record 00897392002640
- FDA 510(k) database K111282
Across registries
- FDA 510(k) K111282 decided 11 Aug 2011 Active
- FDA GUDID UDI-DI 00897392002640 listed 19 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K111282
- Listed FDA GUDID 00897392002640
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- sourcemark
- Generic name
- General-purpose patient temperature probe, single-use
- Model / reference
- SM400TYP
- Primary DI / UDI-DI
- 00897392002640
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- General-purpose patient temperature probe, single-use
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
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