Cleared Traditional

IMPERIUM

K953905 · Teledyne Brown Engineering · Physical Medicine

Nov 1995

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K953905 is an FDA 510(k) clearance for the IMPERIUM, a System, Environmental Control, Powered (Class II — Special Controls, product code IQA), submitted by Teledyne Brown Engineering (Huntsville, US). The FDA issued a Cleared decision on November 21, 1995, 95 days after receiving the submission on August 18, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3725.

Submission Details

510(k) Number	K953905 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 1995
Decision Date	November 21, 1995
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF