DIGITAL FOREHEAD THERMOMETER
FDA 510(k) clearance K103617 · decided 2011-04-04
Clearance details
- K-number
- K103617
- Device name
- DIGITAL FOREHEAD THERMOMETER
- Applicant
- K-Jump Health Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-10
- Decision date
- 2011-04-04
- Days to decision
- 115 days
- Clearance type
- Special
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Taipei Hsien, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kro recall (Z-0412-2016) | Bestmed, LLC | 2015-12-16 |