BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER— 510(k) K992468
Substantially EquivalentBraun GmbH
FDA 510(k) clearance K992468 for BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER, Substantially Equivalent on 1999-10-20. Applicant: Braun GmbH. Device class: 2.
Clearance details
- Applicant
- Braun GmbH
- 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
- Traditional
- Location
- San Diego, CA, US
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More clearances from Braun GmbH
view all- K061351 — ORAL-B SONIC COMPLETE
- K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
- K060006 — BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
- K031928 — BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)
- K012035 — BRAUN PRECISION SENSOR PRO, MODEL BP 2590
Adverse 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.