The following data is part of a premarket notification filed by Podimetrics, Inc. with the FDA for Podimetrics Remote Temperature Monitoring System.
| Device ID | K150557 |
| 510k Number | K150557 |
| Device Name: | Podimetrics Remote Temperature Monitoring System |
| Classification | Foot Examination Tool For Inflammatory Changes |
| Applicant | Podimetrics, Inc. 231 R Holland Street Somerville, MA 02144 |
| Contact | Jon Bloom |
| Correspondent | Jon Bloom Podimetrics, Inc. 231 R Holland Street Somerville, MA 02144 |
| Product Code | OIZ |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-04 |
| Decision Date | 2015-10-08 |
| Summary: | summary |