Cleared Traditional

THERMOLATOR HEATING UNIT

K801625 · Tru-Eze Mfg. Co., Inc. · Physical Medicine

Jul 1980

Decision

13d

Days

Class 1

Risk

About This 510(k) Submission

K801625 is an FDA 510(k) clearance for the THERMOLATOR HEATING UNIT, a Unit, Heating, Powered (Class I — General Controls, product code IRQ), submitted by Tru-Eze Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 13 days after receiving the submission on July 15, 1980. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number	K801625 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 1980
Decision Date	July 28, 1980
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—