FDA 510(k) Application Details - K111742

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K111742
Device Name	Ventilatory Effort Recorder
Applicant	EMBLA SYSTEMS 9351 GRANT STREET SUITE 600 THORNTON, CO 80229 US Other 510(k) Applications for this Company
Contact	ROBERT G SCHUEPPERT 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	06/21/2011
Decision Date	08/31/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review