Cleared Traditional

K902664 - HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1
(FDA 510(k) Clearance)

K902664 · Prentke Romich Co. · Physical Medicine device

Jul 1990

Decision

37d

Days

Class 2

Risk

K902664 is an FDA 510(k) clearance for the HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1. This device is classified as a System, Environmental Control, Powered (Class II - Special Controls, product code IQA).

Submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on July 25, 1990, 37 days after receiving the submission on June 18, 1990.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3725.

Submission Details

510(k) Number	K902664 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 18, 1990
Decision Date	July 25, 1990
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—