FDA 510(k) Application Details - K122560

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K122560
Device Name	Ventilator, Continuous, Facility Use
Applicant	PAN-AMERICA HYPERBARICS, INC. 1510 PARK PLACE DRIVE ATCHISON, KS 66002 US Other 510(k) Applications for this Company
Contact	WILLIAM M GATES, RRT Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2012
Decision Date	03/26/2013
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