EMS PEEP VALVES- ADJUSTABLE

Attachment, Breathing, Positive End Expiratory Pressure

ENGINEERED MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Peep Valves- Adjustable.

Pre-market Notification Details

Device IDK983920
510k NumberK983920
Device Name:EMS PEEP VALVES- ADJUSTABLE
ClassificationAttachment, Breathing, Positive End Expiratory Pressure
Applicant ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis,  IN  46268
ContactJeff Quinn
CorrespondentJeff Quinn
ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis,  IN  46268
Product CodeBYE  
CFR Regulation Number868.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-04
Decision Date1999-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841470111066 K983920 000
10841470111035 K983920 000
10841470110984 K983920 000
10841470110991 K983920 000
10841470111004 K983920 000
10841470111011 K983920 000
10841470111028 K983920 000
10841470111042 K983920 000
10841470111059 K983920 000
10841470111431 K983920 000

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