MODEL APS ALTERNANS PROCESSING SYSTEM

Electrocardiograph

CAMBRIDGE HEART, INC.

The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Model Aps Alternans Processing System.

Pre-market Notification Details

Device IDK001034
510k NumberK001034
Device Name:MODEL APS ALTERNANS PROCESSING SYSTEM
ClassificationElectrocardiograph
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 CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-31
Decision Date2000-06-09

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