Home / 510(k) Clearances / K925484

510(k) K925484

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 by Bruel & Kjaer — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1993
Date Received
October 30, 1992
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 Bruel & Kjaer

  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (April 10, 1992)
  • K905198 — DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 (August 28, 1991)
  • K911348 — RIGID ENDOSCOPE (June 21, 1991)

Other clearances for product code CCK

  • K250148 — Medical Gas Analyzer (AG200) (August 28, 2025)
  • K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (June 10, 2025)
  • K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO (June 4, 2025)
  • K240937 — AIM (N/A) (December 16, 2024)
  • K230915 — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (November 12, 2024)
  • K212425 — MicroTrend System (November 7, 2024)
  • 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)