EMS ELECTROSTATIC FLITER AND HME COMBINATION

Filter, Bacterial, Breathing-circuit

ENGINEERED MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Electrostatic Fliter And Hme Combination.

Pre-market Notification Details

Device IDK013122
510k NumberK013122
Device Name:EMS ELECTROSTATIC FLITER AND HME COMBINATION
ClassificationFilter, Bacterial, Breathing-circuit
Applicant ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville,  IN  46055
ContactPaul Dryden
CorrespondentPaul Dryden
ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville,  IN  46055
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-19
Decision Date2002-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10841470108073 K013122 000
00841470108007 K013122 000
00841470103453 K013122 000
10841470103443 K013122 000
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00841470109868 K013122 000
00841470110079 K013122 000
10841470109810 K013122 000
00841470110741 K013122 000
00841470110734 K013122 000
10841470110519 K013122 000
10841470110496 K013122 000
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10841470110472 K013122 000
10841470110458 K013122 000
10841470110441 K013122 000
00841470110376 K013122 000
10841470105454 K013122 000

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