FDA 510(k) Application Details - K150102

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K150102
Device Name	Ventilatory Effort Recorder
Applicant	APPIAN MEDICAL, INC. 502 SCRIMSHAW WAY SEVEMA PARK, MD 21146 US Other 510(k) Applications for this Company
Contact	MICHAEL J THOMAS 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	01/20/2015
Decision Date	11/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review