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510(k) K082655

ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 by Envitec-Wismar GmbH — Product Code CCL

K082655 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106". The FDA issued a decision of Substantially Equivalent on November 25, 2008. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Envitec-Wismar GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2008
Date Received
September 12, 2008
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 Envitec-Wismar GmbH

  • K133064 — MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, (May 2, 2014)
  • K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (January 23, 2013)
  • K102270 — ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN (February 22, 2011)
  • K090438 — REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414 (July 24, 2009)
  • K070193 — ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES (May 2, 2007)
  • K060675 — ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS (July 17, 2006)
  • K043463 — ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS (February 11, 2005)
  • K992215 — MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOS (March 29, 2000)

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)

FDA data resources