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510(k) K040484

MAXO2+, MODEL A AND AE by Maxtec, Inc. — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2004
Date Received
February 25, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

Other clearances by Maxtec, Inc.

  • K231895 — Maxtec MaxBlend2+p (December 4, 2023)
  • K221734 — Maxtec MaxO2 ME+p (April 1, 2023)
  • K182362 — MaxCap Ped and MaxCap Neo (May 23, 2019)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • 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)

Other clearances for product code CCL

  • K251245 — OxyMinder Pro (10310) (August 11, 2025)
  • K250002 — Smart Check O2 (MA0236) (April 24, 2025)
  • K221734 — Maxtec MaxO2 ME+p (April 1, 2023)
  • K213933 — Percent Oxygen Sensors (August 19, 2022)
  • K213948 — OxyMinder (March 17, 2022)
  • K173807 — Accu O2 Oxygen Analyzer (May 2, 2018)
  • K153659 — MaxO2ME (June 10, 2016)
  • K123195 — CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (February 28, 2013)
  • K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (January 23, 2013)
  • K112402 — ULTRAMAXO2 OXYGEN ANALYER (December 14, 2011)