Clearance Summary
THEMALATOR. MODELS T-4-S, T-8-S, ETC. received FDA 510(k) clearance under submission number K950350, sponsored by Whitehall/Div Columbus Mckennon Corp.. 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 1995-03-24.
- Submission: K950350
- Applicant / Sponsor: Whitehall/Div Columbus Mckennon Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5950
- Decision date: 1995-03-24
Classification & Regulation
This clearance is catalogued under FDA product code IRQ and 21 CFR 890.5950, within the Physical Medicine review panel as a Class I device.