Cleared Traditional

K943035 - P.A.T. SYSTEM
(FDA 510(k) Clearance)

K943035 · Mathews Assoc., Inc. · Physical Medicine device

Oct 1994

Decision

99d

Days

Class 2

Risk

K943035 is an FDA 510(k) clearance for the P.A.T. SYSTEM. This device is classified as a System, Communication, Powered (Class II - Special Controls, product code ILQ).

Submitted by Mathews Assoc., Inc. (Sanford, US). The FDA issued a Cleared decision on October 4, 1994, 99 days after receiving the submission on June 27, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3710.

Submission Details

510(k) Number	K943035 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 27, 1994
Decision Date	October 04, 1994
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement