BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
FDA 510(k) clearance K103800 · decided 2011-01-26
Clearance details
- K-number
- K103800
- Device name
- BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
- Applicant
- Kaz USA, Inc (A Subsidiaryof Kaz Inc)
- Decision
- Substantially Equivalent
- Date received
- 2010-12-28
- Decision date
- 2011-01-26
- Days to decision
- 29 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.