510(k) K843811

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

K843811 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "BUNN 3001 OXYGEN CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on October 4, 1984. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. The John Bunn Co. has at least 10 other 510(k) clearances on record.

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