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FDA 510(k) Application Details - K130752
Device Classification Name
Monitor, Bed Patient
More FDA Info for this Device
510(K) Number
K130752
Device Name
Monitor, Bed Patient
Applicant
CENTAURI MEDICAL, INC.
755 N MATHILDA AVE STE 100
SUNNYVALE, CA 94085 US
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Contact
LORI ADELS
Other 510(k) Applications for this Contact
Regulation Number
880.2400
More FDA Info for this Regulation Number
Classification Product Code
KMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/19/2013
Decision Date
08/15/2013
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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