CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM

Electrocardiograph

CAMBRIDGE HEART, INC.

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

Pre-market Notification Details

Device IDK950018
510k NumberK950018
Device Name:CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
ClassificationElectrocardiograph
Applicant CAMBRIDGE HEART, INC. ONE OAK PARK DR. Bedford,  MA  01730
ContactM Arie
CorrespondentM Arie
CAMBRIDGE HEART, INC. ONE OAK PARK DR. Bedford,  MA  01730
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-03
Decision Date1996-02-29

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