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FDA 510(k) Application Details - K141877
Device Classification Name
Monitor, Bed Patient
More FDA Info for this Device
510(K) Number
K141877
Device Name
Monitor, Bed Patient
Applicant
LEAF HEALTHCARE, INC.
755 N MATHILDA AVE.
SUITE 100
SUNNYVALE, CA 94085 US
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Contact
RONALD S WARREN
Other 510(k) Applications for this Contact
Regulation Number
880.2400
More FDA Info for this Regulation Number
Classification Product Code
KMI
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More FDA Info for this Product Code
Date Received
07/11/2014
Decision Date
11/10/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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