Braun Thermoscan PRO 6000 Ear Thermometer— 510(k) K152748
Substantially EquivalentKaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
FDA 510(k) clearance K152748 for Braun Thermoscan PRO 6000 Ear Thermometer, Substantially Equivalent on 2016-03-01. Applicant: Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc).
Clearance details
- Applicant
- Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
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.