ACTA GENOS ELECTROCARDIOGRAPH

Electrocardiograph

PAREXEL INTL. CORP.

The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Acta Genos Electrocardiograph.

Pre-market Notification Details

Device IDK884800
510k NumberK884800
Device Name:ACTA GENOS ELECTROCARDIOGRAPH
ClassificationElectrocardiograph
Applicant PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge,  MS  02140
ContactSayigh, Phd
CorrespondentSayigh, Phd
PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge,  MS  02140
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-16
Decision Date1989-06-22

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