Podimetrics Remote Temperature Monitoring System
FDA 510(k) clearance K150557 · decided 2015-10-08
Clearance details
- K-number
- K150557
- Device name
- Podimetrics Remote Temperature Monitoring System
- Applicant
- Podimetrics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-04
- Decision date
- 2015-10-08
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- OIZ
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Somerville, MA, 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 |
|---|---|---|
| VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT (K080816) | Visual Footcare Technologies, LLC | 2008-06-24 |
Recalls involving this device
No recalls on record reference this clearance.