VENTILATOR TEST LUNG

Ventilator, Continuous, Facility Use

BIO-MED DEVICES, INC.

The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for Ventilator Test Lung.

Pre-market Notification Details

Device IDK800125
510k NumberK800125
Device Name:VENTILATOR TEST LUNG
ClassificationVentilator, Continuous, Facility Use
Applicant BIO-MED DEVICES, INC. 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 Received1980-01-18
Decision Date1980-01-24

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