Clearance Summary
THERMAFLEX, MODEL SD 55 C.P.M.H. received FDA 510(k) clearance under submission number K945803, sponsored by Burke Neutech, 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 1995-05-11.
- Submission: K945803
- Applicant / Sponsor: Burke Neutech, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5410
- Decision date: 1995-05-11
Classification & Regulation
This clearance is catalogued under FDA product code JFA and 21 CFR 890.5410, within the Physical Medicine review panel as a Class I device.