FDA 510(k) Application Details - K921821

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K921821
Device Name Ventilator, Continuous, Facility Use
Applicant BIOMAGNETIC TECHNOLOGIES, INC.
9021 45TH AVE N.
NEWHOPE, MN US
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Contact MICHAEL J BOYLE
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 04/16/1992
Decision Date 11/02/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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