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FDA 510(k) Application Details - K952880
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
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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More FDA Info for this Product Code
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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