PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH

Electrocardiograph

PAREXEL INTL. CORP.

The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Personal C3 3-channel Electrocardiograph.

Pre-market Notification Details

Device IDK851322
510k NumberK851322
Device Name:PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH
ClassificationElectrocardiograph
Applicant PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge,  MA  02138
ContactJulian P Kaye
CorrespondentJulian P Kaye
PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge,  MA  02138
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-02
Decision Date1985-05-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.