CBG CUFF MANOMETER

Cuff, Tracheal Tube, Inflatable

BIO-MED DEVICES, INC.

The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for Cbg Cuff Manometer.

Pre-market Notification Details

Device IDK873614
510k NumberK873614
Device Name:CBG CUFF MANOMETER
ClassificationCuff, Tracheal Tube, Inflatable
Applicant BIO-MED DEVICES, INC. 8 BISHOP LN. Madison,  CT  06443
ContactDean J Bennett
CorrespondentDean J Bennett
BIO-MED DEVICES, INC. 8 BISHOP LN. Madison,  CT  06443
Product CodeBSK  
CFR Regulation Number868.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-08
Decision Date1988-01-22

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