Clearance Summary
Podimetrics Remote Temperature Monitoring System received FDA 510(k) clearance under submission number K150557, sponsored by Podimetrics,Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2015-10-08.
- Submission: K150557
- Applicant / Sponsor: Podimetrics,Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5050
- Decision date: 2015-10-08
Classification & Regulation
This clearance is catalogued under FDA product code OIZ and 21 CFR 890.5050, within the Physical Medicine review panel as a Class I device.