IC-5 VENTILATOR

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 Ic-5 Ventilator.

Pre-market Notification Details

Device IDK813253
510k NumberK813253
Device Name:IC-5 VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant BIO-MED DEVICES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-19
Decision Date1981-12-09

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