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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

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

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  • 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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