Cleared Traditional

BEDSIDE BUTLER

K944345 · Trac Medical, Inc. · Physical Medicine

Oct 1994

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K944345 is an FDA 510(k) clearance for the BEDSIDE BUTLER, a System, Environmental Control, Powered (Class II — Special Controls, product code IQA), submitted by Trac Medical, Inc. (Raliegh, US). The FDA issued a Cleared decision on October 17, 1994, 41 days after receiving the submission on September 6, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3725.

Submission Details

510(k) Number	K944345 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1994
Decision Date	October 17, 1994
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF