CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000

Computer, Diagnostic, Programmable

CAMBRIDGE HEART, INC.

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

Pre-market Notification Details

Device IDK983102
510k NumberK983102
Device Name:CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
ClassificationComputer, Diagnostic, Programmable
Applicant CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale,  FL  33332
ContactJohn D Greenbaum
CorrespondentJohn D 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 Received1998-09-03
Decision Date1999-04-12
Summary:summary

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