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510(k) K140113

O2 NASAL CANNULA WITH CO2 MONITORING by Flexicare Medical, Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2014
Date Received
January 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Flexicare Medical, Ltd.

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  • K140473 — DUALGUARD (April 10, 2014)
  • K132619 — CLASSIC INTERMITTENT CATHETER (October 11, 2013)
  • K092218 — FLEXICARE BREATHING FILTERS (October 6, 2009)
  • K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBES (June 17, 2009)
  • K951652 — VENTIMASK MK IV (April 27, 1995)

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