FDA 510(k) Application Details - K130752

Device Classification Name Monitor, Bed Patient

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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
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Regulation Number 880.2400

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Classification Product Code KMI
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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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