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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
Predetermined Change
Control Plan Authorized		 No
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