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FDA 510(k) Application Details - K181216
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K181216
Device Name
Ventilator, Continuous, Facility Use
Applicant
Hamilton Medical AG
Via Crusch 8
Bonaduz 7402 CH
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Contact
Katrin Vogt
Other 510(k) Applications for this Contact
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
05/07/2018
Decision Date
08/02/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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