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FDA 510(k) Application Details - K190775
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K190775
Device Name
Monitor, Breathing Frequency
Applicant
Shenzhen Fiber Medical Technology Co. Ltd.
Room 501, Sun Mate Science and Technology Mansion
2009 Shahe West Road
Shenzhen 518057 CN
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Contact
Luo Li
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
BZQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2019
Decision Date
12/19/2019
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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