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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Biopotential
510(k) Number K914381
Device Name HORIZON 9000/HIS OPTION AMPLIFIER
Applicant
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Applicant Contact RONALD A BRANDT
Correspondent
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Correspondent Contact RONALD A BRANDT
Regulation Number870.2050
Classification Product Code
DRR  
Date Received10/03/1991
Decision Date 01/28/1992
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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