510(k) K050414

PLIX by Respironics, Inc. — Product Code BYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2005
Date Received
February 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
Review Panel
AN
Submission Type