Home / 510(k) Clearances / K181624

510(k) K181624

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line by Oridion Medical 1987 , Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2019
Date Received
June 20, 2018
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

Other clearances by Oridion Medical 1987 , Ltd.

  • K200594 — Capnostream 35 Portable Respiratory Monitor (April 27, 2020)
  • K181467 — Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Ad (February 8, 2019)
  • 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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  • K222511 — Oxy2Pro (November 21, 2023)
  • K213767 — Endure ETCO2/02 Nasal Cannula (September 12, 2023)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K210112 — XChange Device, XChange System (January 30, 2023)