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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K840169
Device Name PHONOANGIOGRAPHIC SPECTRAL ANALYZER
Applicant
Biotronics Instruments
12020 W. Ripley Ave.
Wauwatosa,  WI  53226
Applicant Contact KEN SCHLAGER
Correspondent
Biotronics Instruments
12020 W. Ripley Ave.
Wauwatosa,  WI  53226
Correspondent Contact KEN SCHLAGER
Regulation Number870.2100
Classification Product Code
DPW  
Date Received01/16/1984
Decision Date 03/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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