510(k) K912356

GROUP AUDITORY TRAINER,FM RECEIVER by Phonic Ear, Inc. — Product Code EPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1991
Date Received
May 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Group And Auditory Trainer
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type