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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K851335
Device Name COACH TM- THE AEROBIC FITNESS MONITOR
Applicant
Biotechnology, Inc.
6924 NW 46th. St.
Miami,  FL  33166
Applicant Contact FRANK J BIANCO
Correspondent
Biotechnology, Inc.
6924 NW 46th. St.
Miami,  FL  33166
Correspondent Contact FRANK J BIANCO
Regulation Number870.2300
Classification Product Code
DRT  
Date Received04/03/1985
Decision Date 07/24/1985
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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