510(k) K960229

RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM by Resound Corp. — Product Code ETW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1996
Date Received
January 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type