5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
FDA 510(k) clearance K050303 · decided 2005-02-25
Clearance details
- K-number
- K050303
- Device name
- 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
- Applicant
- Mesure Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-08
- Decision date
- 2005-02-25
- Days to decision
- 17 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.