FDA 510(k) Application Details - K090138

Device Classification Name	Monitor, Bed Patient   More FDA Info for this Device
510(K) Number	K090138
Device Name	Monitor, Bed Patient
Applicant	AFRAME DIGITAL, INC. 15637 FOX COVE CIRCLE MOSELEY, VA 23120 US Other 510(k) Applications for this Company
Contact	DARREN REEVES 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	01/21/2009
Decision Date	04/24/2009
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