510(k) K843811

BUNN 3001 OXYGEN CONCENTRATOR by The John Bunn Co. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1984
Date Received
September 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type