FDA 510(k) Application Details - K952880

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K952880
Device Name Ventilator, Continuous, Facility Use
Applicant AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS, MN 55447 US
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Contact ROBERT C SAMEC
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 06/22/1995
Decision Date 06/20/1996
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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