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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 K022152
Device Name HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
Applicant
Cambridge Heart, Inc.
20310 SW 48th St.
South West Ranches,  FL  33332
Applicant Contact JOHN GREENBAUM
Correspondent
Cambridge Heart, Inc.
20310 SW 48th St.
South West Ranches,  FL  33332
Correspondent Contact JOHN GREENBAUM
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
Date Received07/02/2002
Decision Date 07/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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