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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K896380
Device Name IC-2A MRI ADULT/PEDIATRIC VENTILATOR
Applicant
BIO-MED DEVICES, INC.
8 BISHOP LN.
MADISON,  CT  06443
Applicant Contact DEAN J BENNETT
Correspondent
BIO-MED DEVICES, INC.
8 BISHOP LN.
MADISON,  CT  06443
Correspondent Contact DEAN J BENNETT
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/06/1989
Decision Date 02/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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