FDA 510(k) Application Details - K081485

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K081485
Device Name	Ventilatory Effort Recorder
Applicant	SOMNOMEDICS GMBH 901 KING STREET SUITE 200 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	CHERITA JAMES 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	05/28/2008
Decision Date	09/18/2008
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