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FDA 510(k) Application Details - K220107
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K220107
Device Name
Ventilator, Continuous, Facility Use
Applicant
Shenzhen Mindray Bio-medical Electronics Co.,LTD.
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen 518057 CN
Other 510(k) Applications for this Company
Contact
Yanhong Bai
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
01/12/2022
Decision Date
06/16/2023
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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