VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
FDA 510(k) clearance K080816 · decided 2008-06-24
Clearance details
- K-number
- K080816
- Device name
- VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
- Applicant
- Visual Footcare Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-03-24
- Decision date
- 2008-06-24
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- OIZ
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- South Salem, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Podimetrics Remote Temperature Monitoring System (K150557) | Podimetrics,Inc. | 2015-10-08 |
Recalls involving this device
No recalls on record reference this clearance.