FDA 510(k) Application Details - K002159

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K002159
Device Name	Ventilatory Effort Recorder
Applicant	SAGATECH ELECTRONICS, INC. 3413 8TH ST., S.E. CALGARY, ALBERTA T2G3A4 CA Other 510(k) Applications for this Company
Contact	HEATHER PLATT-MELAX 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	07/17/2000
Decision Date	06/28/2002
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