HEARTWAVE II CARDIAC DIAGNOSTIC 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 Heartwave Ii Cardiac Diagnostic System.

Pre-market Notification Details

Device IDK050225
510k NumberK050225
Device Name:HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Southwest Ranches,  FL  33332
ContactJohn Greenbaum
CorrespondentJohn Greenbaum
CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Southwest Ranches,  FL  33332
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-01
Decision Date2005-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522121852 K050225 000
10841522118432 K050225 000
10841522118449 K050225 000
10841522118456 K050225 000
10841522123832 K050225 000
10841522121920 K050225 000
10841522121913 K050225 000
10841522121814 K050225 000
10841522121845 K050225 000
10841522118425 K050225 000

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