ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

Computer, Diagnostic, Programmable

CAMBRIDGE HEART, INC.

The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Alternanas Processing System, Ch 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System.

Pre-market Notification Details

Device IDK012206
510k NumberK012206
Device Name:ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale,  FL  33332
ContactJohn Greenbaum
CorrespondentJohn Greenbaum
CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale,  FL  33332
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-13
Decision Date2001-10-12
Summary:summary

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