510(k) K150557
- Device
- Podimetrics Remote Temperature Monitoring System
- Applicant
- Podimetrics, Inc.
- 510(k) number
- K150557
- Product code
- OIZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-08
- Date received
- 2015-03-04
- 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
- Jon Bloom
- Address
- 231 R Holland St. Somerville MA US 02144 02144
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 |
|---|---|---|---|
| K080816 | VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT | Visual Footcare Technologies, LLC | 2008-06-24 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases