FDA 510(k) Application Details - K101109

Device Classification Name	Monitor, Bed Patient   More FDA Info for this Device
510(K) Number	K101109
Device Name	Monitor, Bed Patient
Applicant	WIRELESS MEDCARE, LLC 1733 CANTON LANE MARIETTA, GA 30062 US Other 510(k) Applications for this Company
Contact	PAUL SUMNER 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	04/20/2010
Decision Date	07/15/2010
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