FDA 510(k) Application Details - K021138

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K021138
Device Name	Ventilatory Effort Recorder
Applicant	ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. YORBA LINDA, CA 92887-4645 US Other 510(k) Applications for this Company
Contact	BRIAN LONG 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	04/09/2002
Decision Date	02/12/2003
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