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510(k) K153659

MaxO2ME by Maxtec, LLC — Product Code CCL

K153659 is an FDA 510(k) premarket notification submitted by Maxtec, LLC for the device "MaxO2ME". The FDA issued a decision of Substantially Equivalent on June 10, 2016. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Maxtec, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2016
Date Received
December 21, 2015
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, LLC

  • 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)
  • 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)

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)
  • 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)
  • K082655 — ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM (November 25, 2008)

FDA data resources