INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM

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 Multiview Infinity Telemetry System.

Pre-market Notification Details

Device IDK060223
510k NumberK060223
Device Name:INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
ContactKaren A Iorio
CorrespondentKaren A Iorio
Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-30
Decision Date2006-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049098005067 K060223 000

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