Cleared Traditional

SPEECH TEACHER

K840112 · Joseph A. Resnick · Physical Medicine

Mar 1984

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K840112 is an FDA 510(k) clearance for the SPEECH TEACHER, a System, Communication, Non-powered (Class I — General Controls, product code ILP), submitted by Joseph A. Resnick (Mchenry, US). The FDA issued a Cleared decision on March 22, 1984, 73 days after receiving the submission on January 9, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3700.

Submission Details

510(k) Number	K840112 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 09, 1984
Decision Date	March 22, 1984
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—