510(k) K080816
- Device
- VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
- Applicant
- VISUAL FOOTCARE TECHNOLOGIES, LLC
- 510(k) number
- K080816
- Product code
- OIZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-24
- Date received
- 2008-03-24
- Regulation
- 890.5050
- Classification name
- Foot Examination Tool For Inflammatory Changes
- Medical specialty
- Physical Medicine
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW SINGER
- Address
- P.O. Box 760 South Salem NY US 10590 10590
FDA Registration Numbers#
- 3004541594
- 3012492422
- 3022516134
- 3026071490
- 3003771601
- 3004526603
- 3003695829
- 3022140314
- 3012421607
- 3018056766
- 3009757062
- 3033884638
- 3015542388
Source Documents#
Other 510(k) Records For Product Code OIZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150557 | Podimetrics Remote Temperature Monitoring System | Podimetrics,Inc. | 2015-10-08 |
Legacy Summary#
summary
FDA Review#
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