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510(k) K202480

Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 by Parker Hannifin — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2021
Date Received
August 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

Other clearances by Parker Hannifin

  • K161731 — Cleveland Multiport Ventricular Catheter Set (March 27, 2017)
  • K897086 — PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 (September 28, 1990)
  • K863532 — MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER (January 14, 1987)
  • K833723 — MODEL 2000 AMBULATORY MED. INFUSER (January 30, 1984)
  • K834461 — INFUSION PUMP PRIMER (January 30, 1984)
  • K831402 — PRESSURE MONITOR & CONTROL UNIT APC-02A (August 8, 1983)
  • K831747 — PLASMA THERAPY TUBESET-E100 SERIES (June 30, 1983)
  • K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A & (April 12, 1983)

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  • K231895 — Maxtec MaxBlend2+p (December 4, 2023)
  • K230987 — FlowStar Analog Mixer Flowmeter (September 14, 2023)
  • K222794 — FlowStar Touch Digital Mixer Flowmeter (July 28, 2023)
  • K221494 — Quality Mix Blender, Oxymixer (January 23, 2023)
  • K173205 — Equinox Advantage (August 29, 2018)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)
  • K113687 — EQUINOX RELIEVE (April 30, 2012)