PNEUPAC VENTILATOR/RESUSCITATOR #3

Ventilator, Continuous, Facility Use

PNEU PAC, LTD.

The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Pneupac Ventilator/resuscitator #3.

Pre-market Notification Details

Device IDK792456
510k NumberK792456
Device Name:PNEUPAC VENTILATOR/RESUSCITATOR #3
ClassificationVentilator, Continuous, Facility Use
Applicant PNEU PAC, LTD. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-12-03
Decision Date1980-02-05

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