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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K850007
Device Name ACOUSTIC OTOCOPE RECORDER
Applicant
Endeco Medical, Inc.
13 Atlantis Dr.
Marion,  MA  02738
Applicant Contact RUSSELL N CHUTE
Correspondent
Endeco Medical, Inc.
13 Atlantis Dr.
Marion,  MA  02738
Correspondent Contact RUSSELL N CHUTE
Regulation Number874.1090
Classification Product Code
ETY  
Date Received01/02/1985
Decision Date 03/01/1985
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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