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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 K862086
Device Name IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
Applicant
A/S Bruel & Kjaer
18, Naerum Hovedgade
Dk-2850 Naerum
Denmark,  DK
Applicant Contact AAGE RUBY
Correspondent
A/S Bruel & Kjaer
18, Naerum Hovedgade
Dk-2850 Naerum
Denmark,  DK
Correspondent Contact AAGE RUBY
Regulation Number874.3310
Classification Product Code
ETW  
Date Received06/02/1986
Decision Date 07/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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