NGM ESTP MODULE

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

DATEX DIVISION INSTRUMENTARIUM CORP.

The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Ngm Estp Module.

Pre-market Notification Details

Device IDK911646
510k NumberK911646
Device Name:NGM ESTP MODULE
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant DATEX DIVISION INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury,  MA  01876
ContactVincent Rauscher
CorrespondentVincent Rauscher
DATEX DIVISION INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury,  MA  01876
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-15
Decision Date1992-02-21

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