FDA 510(k) Application Details - K070263

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K070263
Device Name	Ventilatory Effort Recorder
Applicant	RESMED GERMANY INC. 14040 DANIELSON ST. POWAY, CA 92064-6857 US Other 510(k) Applications for this Company
Contact	DAVID D'CRUZ Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	MNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2007
Decision Date	06/15/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review