Cosense Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Full name

Cosense

510(k) Number

K121768 ↗

FDA product code

CCJ

Device class

Class II

Regulation

21 CFR Part 868.1430

Advisory committee

Anesthesiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase).

• SPIROLOOP, MODIFICATION by Pneumedics, Inc.
• VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR by Vitalograph, Ltd.
• DIFFUSION OPTION, OMNI-LAB by Airco/Ohio Medical Products
• Minico by Catalyst Research Corp.
• MICROCO by Micro Direct, Inc.
• EC50 TOXCO+ Breath Carbon Monoxide Monitor by Bedfont Scientific Ltd
• Ecolyzer #200/COHB Analyzer Sys by Bd Becton Dickinson Vacutainer Systems Preanalytic
• Carbon Monoxide Breath Sensor System (COBSS) by Carrot Sense, Inc.
• iCOquit Smokerlyzer by Bedfont Scientific Ltd
• VITALOGRAPH-BREATHCO MONITOR by Vitalograph, Ltd.

• CO Sensor Module C20302 Open recall

  Class II

  FDA 510(k) ×3 Active Cleared 31 Oct 2012 GUDID on market

• CoSense Precision Sampling Set C20206 Open recall

  Class II

  FDA 510(k) ×3 Active Cleared 31 Oct 2012 GUDID on market

• CoSense ETCO Monitor C20112 Open recall

  Class II

  FDA 510(k) ×4 K253119 Active Cleared 29 May 2026 GUDID on market

• CoSense ETCO Monitor Open recall

  Class II

  FDA 510(k) K151107 Active Cleared 22 Jul 2015

See all devices from Capnia, Inc. →