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510(k) K093388

SMART CAPNOLINE GUARDIAN by Oridion Medical 1987 , Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2010
Date Received
October 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K042665 — SMART BITEBLOC (November 23, 2004)
  • K024300 — MICROCAP PLUS/NPB-75 (April 3, 2003)
  • K013845 — MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE (November 29, 2001)

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