FDA 510(k) Application Details - K051222

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K051222
Device Name	Ventilator, Continuous, Facility Use
Applicant	PENLON LIMITED Abingdon Science Park Barton Lane, Abingdon Oxon OX14 3NB GB Other 510(k) Applications for this Company
Contact	BARRY PEARCE 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	05/12/2005
Decision Date	09/23/2005
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