EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
FDA 510(k) clearance K042627 · decided 2004-10-18
Clearance details
- K-number
- K042627
- Device name
- EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
- Applicant
- Mesure Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-27
- Decision date
- 2004-10-18
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Chung City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.