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510(k) K000948

OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 by Keymed (Medical & Industrial Equipment), Ltd. — Product Code FEQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2000
Date Received
March 23, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Air, Non-Manual, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Keymed (Medical & Industrial Equipment), Ltd.

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  • K100899 — OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (September 13, 2010)
  • K011725 — OLYMPUS SUCTION PUMP, MODEL KV-5 (August 31, 2001)
  • K962528 — OLYMPUS MOBILE CHAIR/COUCH (December 12, 1996)
  • K930852 — OLYMPUS SUCTION PUMP MODEL KV-4 (March 31, 1994)
  • K881478 — MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS (September 14, 1988)

Other clearances for product code FEQ

  • K220395 — EndoGator Endoscopy Irrigation Tubing (March 11, 2022)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO (January 4, 2017)
  • K162152 — Erbe’s CO2 Tubing/Cap Sets (August 31, 2016)
  • K161482 — EndoChoice Water Bottle Cap Irrigation System (June 27, 2016)
  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K153362 — AquaShield system CO2, AquaShield system-PENTAX (December 16, 2015)
  • K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM (January 20, 2015)