FDA 510(k) Application Details - K061256

Device Classification Name	Monitor, Apnea, Home Use   More FDA Info for this Device
510(K) Number	K061256
Device Name	Monitor, Apnea, Home Use
Applicant	RESPIRONICS, INC. 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US Other 510(k) Applications for this Company
Contact	ZITA A YURKO Other 510(k) Applications for this Contact
Regulation Number	868.2377   More FDA Info for this Regulation Number
Classification Product Code	NPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2006
Decision Date	08/02/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review