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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K960229
Device Name RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
Applicant
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Applicant Contact KRISTA M BUCKLES
Correspondent
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Correspondent Contact KRISTA M BUCKLES
Regulation Number874.3310
Classification Product Code
ETW  
Date Received01/17/1996
Decision Date 03/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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