DIGITAL FOREHEAD THERMOMETER, MODEL FS-100
FDA 510(k) clearance K043331 · decided 2005-03-04
Clearance details
- K-number
- K043331
- Device name
- DIGITAL FOREHEAD THERMOMETER, MODEL FS-100
- Applicant
- Hubdic Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-02
- Decision date
- 2005-03-04
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.