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510(k) K781213

COMPRESSOR, AIR, MINI-SILENT by The John Bunn Co. — Product Code BTI

K781213 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "COMPRESSOR, AIR, MINI-SILENT". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
July 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
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)
  • K861435 — BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE (November 7, 1986)
  • 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)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources