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510(k) K231895

Maxtec MaxBlend2+p by Maxtec, LLC — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2023
Date Received
June 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Maxtec, LLC

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  • K153659 — MaxO2ME (June 10, 2016)
  • K133540 — FLOCAP (March 28, 2014)
  • K113232 — MAXMIXING BLOCK (March 1, 2012)
  • K112402 — ULTRAMAXO2 OXYGEN ANALYER (December 14, 2011)
  • K063488 — MAXO2 CU (February 22, 2007)
  • K040484 — MAXO2+, MODEL A AND AE (June 9, 2004)

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  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)
  • K113687 — EQUINOX RELIEVE (April 30, 2012)