VENTIMETER VENTILATOR

Ventilator, Continuous, Facility Use

NARCO AIR-SHIELDS

The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Ventimeter Ventilator.

Pre-market Notification Details

Device IDK790733
510k NumberK790733
Device Name:VENTIMETER VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant NARCO AIR-SHIELDS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-16
Decision Date1979-04-19

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