510(k) K033897

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM by Aga-Linde Health Care — Product Code ECX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2004
Date Received
December 16, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cylinder, Compressed Gas, And Valve
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type