INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM

Detector And Alarm, Arrhythmia

Draeger Medical Systems, Inc.

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

Pre-market Notification Details

Device IDK033305
510k NumberK033305
Device Name:INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
ContactPenelope H Greco
CorrespondentPenelope H Greco
Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-14
Decision Date2003-10-31
Summary:summary

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