510(k) K910819

COMPANION SPEECH AID, MODEL 160 by Companion Products Intl. — Product Code ILQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1991
Date Received
February 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type