INFINITY MONITORS WITH SCIO MODIFICATIONS

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 Monitors With Scio Modifications.

Pre-market Notification Details

Device IDK051628
510k NumberK051628
Device Name:INFINITY MONITORS WITH SCIO MODIFICATIONS
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-20
Decision Date2005-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048675429333 K051628 000
04048675429326 K051628 000
04048675429319 K051628 000
04048675429302 K051628 000

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