INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL

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 Modular Monitors Vf4 Modifications With Scio, Models Delta, Delta Xl, Kappa, Sc 8000, Sc 7000, Sc 9000xl.

Pre-market Notification Details

Device IDK033957
510k NumberK033957
Device Name:INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
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 Received2003-12-22
Decision Date2004-05-14
Summary:summary

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