FDA 510(k) Application Details - K120785

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K120785
Device Name	Generator, Oxygen, Portable
Applicant	CAIRE, INC. 12230 WORLD TRADE DRIVE, SUITE 100 SAN DIEGO, CA 92128 US Other 510(k) Applications for this Company
Contact	BRIAN JARRELL Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2012
Decision Date	10/25/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review