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FDA 510(k) Application Details - K192604
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K192604
Device Name
Ventilator, Continuous, Facility Use
Applicant
Maquet Critica Care AB
R÷ntgenvΣgen 2
Solna 17154 SE
Other 510(k) Applications for this Company
Contact
David Ardanius
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2019
Decision Date
06/18/2020
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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