510(k) K041568

EOCD by Respironics, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2004
Date Received
June 10, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type