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510(k) K780863

MODEL 65 HIGH & LOW PRESSURE ALARM by The John Bunn Co. — Product Code CAP

K780863 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "MODEL 65 HIGH & LOW PRESSURE ALARM". The FDA issued a decision of Substantially Equivalent on August 21, 1978. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1978
Date Received
May 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device Class
Class II
Regulation Number
868.2600
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 CAP

  • K201666 — SINGLE USE MANOMETER (November 13, 2020)
  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K172284 — NAPA LP-15 Airway Pressure Monitor (February 9, 2018)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
  • K122077 — MANOMETER (January 10, 2013)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)

FDA data resources