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510(k) K802011

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 by Pollak (Intl.), Ltd. — Product Code FLN

K802011 is an FDA 510(k) premarket notification submitted by Pollak (Intl.), Ltd. for the device "INFUSSION ALARM SYSTEM I.A.S. CAT.#1118". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Pollak (Intl.), Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
August 20, 1980
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 Pollak (Intl.), Ltd.

  • K000227 — UMBICUT (April 27, 2000)
  • K810049 — PEDICAT* (April 21, 1981)
  • K810050 — VECAFIX* (March 26, 1981)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)
  • K802017 — DRESSING CHANGE SET CAT.#910-930 (October 10, 1980)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)
  • K802016 — EYE APPLICATORS CAT.#980-983 (September 16, 1980)
  • K802013 — FIRST AID BANDAGE CAT.#198 OR 199 (September 16, 1980)
  • K801991 — PLASTIC FORCEPS CAT.#1001-1010 (September 16, 1980)
  • K802001 — LAP SPONGES CAT.#801-850 (September 16, 1980)

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