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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K002230
Device Name CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
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 Number870.2360
Classification Product Code
DRX  
Date Received07/24/2000
Decision Date 08/18/2000
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
Recalls CDRH Recalls
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