ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE

Detector And Alarm, Arrhythmia

PAREXEL INTL. CORP.

The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Acta Metra/acta Gnosis Firmware Package.

Pre-market Notification Details

Device IDK900385
510k NumberK900385
Device Name:ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
ClassificationDetector And Alarm, Arrhythmia
Applicant PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge,  MS  02140
ContactSayigh, Phd
CorrespondentSayigh, Phd
PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge,  MS  02140
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-29
Decision Date1991-07-09

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