FDA 510(k) Application Details - K110486

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K110486
Device Name	Ventilatory Effort Recorder
Applicant	NOVASOM, INC. 801 CROMWELL PARK DRIVE GLEN BURNIE, MD 21061 US Other 510(k) Applications for this Company
Contact	ROGER K RICHARDSON 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	02/22/2011
Decision Date	08/12/2011
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