Cleared Traditional

K953937 - LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM (FDA 510(k) Clearance)

K953937 · Apt Technology, Inc. · Physical Medicine device

Oct 1995

Decision

74d

Days

Class 2

Risk

K953937 is an FDA 510(k) clearance for the LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM. This device is classified as 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 October 31, 1995, 74 days after receiving the submission on August 18, 1995.

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

Submission Details

510(k) Number	K953937 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1995
Decision Date	October 31, 1995
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF