Home / 510(k) Clearances / K941982

510(k) K941982

CAPNOCHECK by Bci, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1994
Date Received
April 25, 1994
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 Bci, Inc.

  • K030407 — ADVISOR, MODEL 9200 (August 19, 2003)
  • K031742 — BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER (August 18, 2003)
  • K020739 — BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR (June 3, 2002)
  • K020350 — BCI 3180 PULSE OXIMETER (April 30, 2002)
  • K013862 — BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM (February 21, 2002)
  • K013171 — 3420 DIGIT PULSE OXIMETER, MODEL 3420 (January 3, 2002)
  • K011156 — BCI 3403 SLEEP SCREENING PULSE OXIMETER (June 14, 2001)
  • K010770 — BCI ADVISOR VITAL SIGNS MONITOR (9200) (June 12, 2001)
  • K011177 — BCI ADVISOR VITAL SIGNS MONITOR (9200) (May 23, 2001)
  • K001770 — BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A (July 5, 2000)

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)