Cleared Traditional

DELTATALKER WITH INFRARED

K961306 · Prentke Romich Co. · Physical Medicine

Jun 1996

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K961306 is an FDA 510(k) clearance for the DELTATALKER WITH INFRARED, a System, Environmental Control, Powered (Class II — Special Controls, product code IQA), submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on June 27, 1996, 84 days after receiving the submission on April 4, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3725.

Submission Details

510(k) Number	K961306 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 1996
Decision Date	June 27, 1996
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement