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510(k) K122290

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE by Envitec-Wismar GmbH — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2013
Date Received
July 30, 2012
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

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  • K090438 — REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414 (July 24, 2009)
  • K082655 — ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM (November 25, 2008)
  • 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)

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  • K112402 — ULTRAMAXO2 OXYGEN ANALYER (December 14, 2011)
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