Infinity M300

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

Draeger Medical Systems, Inc.

The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity M300.

Pre-market Notification Details

Device IDK200859
510k NumberK200859
Device Name:Infinity M300
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Draeger Medical Systems, Inc. 6 Tech Dr. Andover,  MA  01810
ContactThomas Ostrowski
CorrespondentThomas Ostrowski
Draeger Medical Systems, Inc. 6 Tech Dr. Andover,  MA  01810
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2020-08-28

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