DIGITAL CLINICAL THERMOMETER MODEL V901US
FDA 510(k) clearance K112116 · decided 2011-10-04
Clearance details
- K-number
- K112116
- Device name
- DIGITAL CLINICAL THERMOMETER MODEL V901US
- Applicant
- Amperor-Electronic(Sz) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-25
- Decision date
- 2011-10-04
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.