510(k) K934805

HEARIT by Je Liss & Co., Inc. — Product Code LZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1994
Date Received
October 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Assistive Listening
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type