Braun Thermoscan PRO 6000 Ear Thermometer
FDA 510(k) clearance K152748 · decided 2016-03-01
Clearance details
- K-number
- K152748
- Device name
- Braun Thermoscan PRO 6000 Ear Thermometer
- Applicant
- Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
- Decision
- Substantially Equivalent
- Date received
- 2015-09-23
- Decision date
- 2016-03-01
- Days to decision
- 160 days
- Clearance type
- Traditional
- 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
| Record | Firm | Date |
|---|---|---|
| Braun Thermoscan PRO 6000 Ear Thermometer recall (Z-2339-2024) | Baxter Healthcare Corporation | 2024-07-11 |