BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS— 510(k) K103800
Substantially EquivalentKaz USA, Inc (A Subsidiaryof Kaz Inc)
FDA 510(k) clearance K103800 for BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS, Substantially Equivalent on 2011-01-26. Applicant: Kaz USA, Inc (A Subsidiaryof Kaz Inc). Device class: 2.
Clearance details
- Applicant
- Kaz USA, Inc (A Subsidiaryof Kaz Inc)
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Southborough, MA, US
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More clearances from Kaz USA, Inc (A Subsidiaryof Kaz Inc)
view allAdverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.