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FDA 510(k) Application Details - K190734
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K190734
Device Name
Monitor, Breathing Frequency
Applicant
Linshom Management LLC
2922 Excelsior Springs Court
Ellicott City, MD 21042 US
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Contact
Ronen Feldman
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
BZQ
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More FDA Info for this Product Code
Date Received
03/21/2019
Decision Date
01/30/2020
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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