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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 K921821
Device Name IBT MODEL SVI
Applicant
Biomagnetic Technologies, Inc.
9021 45th Ave. N.
Newhope,  MN  55428
Applicant Contact MICHAEL J BOYLE
Correspondent
Biomagnetic Technologies, Inc.
9021 45th Ave. N.
Newhope,  MN  55428
Correspondent Contact MICHAEL J BOYLE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/16/1992
Decision Date 11/02/1992
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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