CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
FDA 510(k) clearance K070028 · decided 2007-02-08
Clearance details
- K-number
- K070028
- Device name
- CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
- Applicant
- Actherm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-03
- Decision date
- 2007-02-08
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Jubei, Hsinchu, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.