MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION

Ventilator, Emergency, Manual (resuscitator)

ENGINEERED MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Modification To Engineered Medical Systems Disposable Manual Resuscitator With Co2 Detection.

Pre-market Notification Details

Device IDK991955
510k NumberK991955
Device Name:MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant ENGINEERED MEDICAL SYSTEMS 2055 EXECUTIVE DR. Indianapolis,  IN  46241
ContactBonnie Holly
CorrespondentBonnie Holly
ENGINEERED MEDICAL SYSTEMS 2055 EXECUTIVE DR. Indianapolis,  IN  46241
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-01
Decision Date1999-07-06
Summary:summary

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