CARDIODAY, VERSION 2.0

Computer, Diagnostic, Programmable

GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG

The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Cardioday, Version 2.0.

Pre-market Notification Details

Device IDK070280
510k NumberK070280
Device Name:CARDIODAY, VERSION 2.0
ClassificationComputer, Diagnostic, Programmable
Applicant GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck,  NY  11021
ContactRomil Rambhia
CorrespondentRomil Rambhia
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck,  NY  11021
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-29
Decision Date2007-02-23
Summary:summary

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