Cleared Traditional

THEMALATOR. MODELS T-4-S, T-8-S, ETC.

K950350 · Whitehall/Div Columbus Mckennon Corp. · Physical Medicine

Mar 1995

Decision

53d

Days

Class 1

Risk

About This 510(k) Submission

K950350 is an FDA 510(k) clearance for the THEMALATOR. MODELS T-4-S, T-8-S, ETC., a Unit, Heating, Powered (Class I — General Controls, product code IRQ), submitted by Whitehall/Div Columbus Mckennon Corp. (City Of Industry, US). The FDA issued a Cleared decision on March 24, 1995, 53 days after receiving the submission on January 30, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number	K950350 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1995
Decision Date	March 24, 1995
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF