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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 K050225
FOIA Releasable 510(k) K050225
Device Name HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
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 Received02/01/2005
Decision Date 04/07/2005
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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