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510(k) K200594

Capnostream 35 Portable Respiratory Monitor by Oridion Medical 1987 , Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2020
Date Received
March 6, 2020
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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  • K150272 — Capnostream 35 Portable Respiratory Monitor (July 17, 2015)
  • K123690 — CAPNOSTREAM20P WITH HIFI C02 MONITORING (August 5, 2014)
  • K121927 — MICROSTREAM FILTERLINE ICU (November 29, 2012)
  • K112368 — CAPNOSTREAM20P WITH AI/ODI (July 19, 2012)
  • K093388 — SMART CAPNOLINE GUARDIAN (March 4, 2010)
  • 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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