Clearance Summary
ULTRATHERM (908) received FDA 510(k) clearance under submission number K964083, sponsored by Sie-Med, 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 1997-04-03.
- Submission: K964083
- Applicant / Sponsor: Sie-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5290
- Decision date: 1997-04-03
Classification & Regulation
This clearance is catalogued under FDA product code IMJ and 21 CFR 890.5290, within the Physical Medicine review panel as a Class II device.