CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS

Transmitters And Receivers, Electrocardiograph, Telephone

INSTROMEDIX, INC.

The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Cardiomagic(r) Software Enhancements.

Pre-market Notification Details

Device IDK950003
510k NumberK950003
Device Name:CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro,  OR  97124 -5898
ContactHerbert J Semler
CorrespondentHerbert J Semler
INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro,  OR  97124 -5898
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-03
Decision Date1995-10-31

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