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FDA 510(k) Application Details - K092062
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K092062
Device Name
Monitor, Breathing Frequency
Applicant
EARLYSENSE LTD.
TZVI 12
RAMAT-GAN 52504 IL
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Contact
DALIA ARGAMAN
Other 510(k) Applications for this Contact
Regulation Number
868.2375
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Classification Product Code
BZQ
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More FDA Info for this Product Code
Date Received
07/08/2009
Decision Date
05/24/2010
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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