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510(k) K821823

I.V. SENTINEL by The John Bunn Co. — Product Code FLN

K821823 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "I.V. SENTINEL". The FDA issued a decision of Substantially Equivalent on August 16, 1982. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1982
Date Received
June 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
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 FLN

  • K172242 — DripAssist Plus (May 25, 2018)
  • K150687 — DripAssist (October 13, 2015)
  • K133870 — FLUID LEVEL MONITOR (April 24, 2014)
  • K080704 — LOW FLUID ALARM (April 17, 2008)
  • K050783 — ISSYS DRUG FLOW MONITOR (February 22, 2006)
  • K060123 — LEVELERT II FLUID LEVEL SENSOR (February 14, 2006)
  • K030136 — DRIP ALERT (April 7, 2003)
  • K022248 — STRYKER L3 HYDROLERT (August 6, 2002)
  • K013121 — MT ALERT INFUSION MONITOR (October 15, 2001)
  • K973025 — FLUID CENTURION (4-100-00) (November 20, 1997)

FDA data resources