DataTherm II
by R.G. Enterprises (U.S.a.), Inc.
DataTherm II (501501) is a Class II device made by R.G. Enterprises (U.S.a.), Inc., cleared under FDA 510(k) K070878 on 5 Jun 2007 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00614801150118), active as of 20 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 | Number00614801150118 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070878 | Date5 Jun 2007 | StatusActive |
Official records
- AccessGUDID record 00614801150118
- FDA 510(k) database K070878
Across registries
- FDA 510(k) K070878 decided 5 Jun 2007 Active
- FDA GUDID UDI-DI 00614801150118 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K070878
- Listed FDA GUDID 00614801150118
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Continuous electronic patient thermometer, battery-powered
- Model / Ref / Catalog
- Datatherm II, 501501
- Primary DI / UDI-DI
- 00614801150118
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Continuous electronic patient thermometer, battery-powered
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).
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