CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

Electrode, Electrocardiograph

CAMBRIDGE HEART, INC.

The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cambridge Heart Micro-v Alternans Sensor, Model 20327-002.

Pre-market Notification Details

Device IDK002230
510k NumberK002230
Device Name:CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
ClassificationElectrode, Electrocardiograph
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 CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-24
Decision Date2000-08-18

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