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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K010758
Device Name HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
Applicant
CAMBRIDGE HEART, INC.
20310 SW 48TH ST.
FT. LAUDERDALE,  FL  33332
Applicant Contact JOHN GREENBAUM
Correspondent
CAMBRIDGE HEART, INC.
20310 SW 48TH ST.
FT. LAUDERDALE,  FL  33332
Correspondent Contact JOHN GREENBAUM
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/13/2001
Decision Date 04/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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