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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K003492
Device Name ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS
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 Number870.1425
Classification Product Code
DQK  
Date Received11/13/2000
Decision Date 01/18/2001
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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