Home / 510(k) Clearances / K861435

510(k) K861435

BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE by The John Bunn Co. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1986
Date Received
April 17, 1986
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

Other clearances by The John Bunn Co.

  • K900854 — JOHN BUNN: MEDIX COMPACT TRAVELLER (April 23, 1990)
  • K883216 — BUNN MODEL 50 OXYGEN FLOW CONTROLLER (August 18, 1988)
  • K873071 — BUNN CONCENTRATOR MODEL 2100 SERIES (September 15, 1987)
  • K870094 — BUNN MODEL 530 ASPIRATOR (March 6, 1987)
  • K861199 — BUNN MODEL 22 OXYGEN FLOW CONTROLLER (August 26, 1986)
  • K862628 — BUNN MODEL 510 MEDICATION COMPRESSOR (August 7, 1986)
  • K855208 — BUNN LITE OXYGEN CONCENTRATOR (February 21, 1986)
  • K860060 — RX02 PLUS OXYGEN CONCENTRATOR (February 5, 1986)
  • K843811 — BUNN 3001 OXYGEN CONCENTRATOR (October 4, 1984)
  • K841102 — BUNN 1000 OXYGEN CONCENTRATOR (April 13, 1984)

Other clearances for product code CAW

  • K251534 — Oxygen Concentrator (J10A) (December 29, 2025)
  • K251764 — Oxygen Concentrator-P2-O5E (December 22, 2025)
  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) (December 16, 2025)
  • K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (December 9, 2025)
  • K251607 — Oxygen Concentrator (J5A) (November 21, 2025)
  • K243833 — Portable oxygen concentrator (JAY-1000P) (September 29, 2025)
  • K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); (August 27, 2025)
  • K251130 — Portable Oxygen Concentrator (JM-P50A) (August 21, 2025)
  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)