Cleared Traditional

DEUCE

K943244 · Apt Technology, Inc. · Physical Medicine

Sep 1995

Decision

432d

Days

Class 2

Risk

About This 510(k) Submission

K943244 is an FDA 510(k) clearance for the DEUCE, a System, Environmental Control, Powered (Class II — Special Controls, product code IQA), submitted by Apt Technology, Inc. (Shreve, US). The FDA issued a Cleared decision on September 11, 1995, 432 days after receiving the submission on July 6, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3725.

Submission Details

510(k) Number	K943244 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 1994
Decision Date	September 11, 1995
Days to Decision	432 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF