DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
FDA 510(k) clearance K041516 · decided 2004-09-08
Clearance details
- K-number
- K041516
- Device name
- DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
- Applicant
- Vega Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-04
- Decision date
- 2004-09-08
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Taipei, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC5512 recall (Z-0506-2012) | Walgreen Company | 2012-01-11 |