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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K926336
Device Name AUDIOSCAN
Applicant
Electrocaine Medical System
Sterling Center,
20-E E. Roseville Rd.
Lancaster,  PA  17601
Applicant Contact STOOLE
Correspondent
Electrocaine Medical System
Sterling Center,
20-E E. Roseville Rd.
Lancaster,  PA  17601
Correspondent Contact STOOLE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received12/16/1992
Decision Date 03/04/1993
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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