CoSense ETCO Monitor

FDA 510(k) K151107 · Capnia, Inc.

Substantially Equivalent

510(k) numberK151107

Submission

Device name
CoSense ETCO Monitor
Applicant
Capnia, Inc.
Redwood City, CA, US
Received
April 27, 2015
Decision date
July 22, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1430
Specialty
Anesthesiology

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K201206Pivot Breath SensorCCJ · Traditional Carrot, Inc.06/30/2021SE
K173238ToxCOCCJ · Traditional Bedfont Scientific, Ltd.04/04/2019SE
K171129CO Check Pro, CO ScreenCCJ · Traditional MD Diagnostics Limited03/02/2018SE
K171408Carbon Monoxide Breath Sensor System (COBSS)CCJ · Traditional Carrot Sense, Inc.09/29/2017SE
K130036Cosense Co MonitorCCJ · Traditional Capnia, Inc.01/14/2014SE
K121768CosenseCCJ · Traditional Capnia, Inc.10/31/2012SE
K082315EC50 Micro+ SmokerlyzerCCJ · Traditional Bedfont Scientific, Ltd.02/01/2010SE
K080278Tabataba CotesterCCJ · Traditional Fim Medical11/28/2008SE

More from Fim Medical

510(k)DeviceDecision
K253119CoSense ETCO MonitorCCJ · Traditional 05/29/2026SE
K130036Cosense Co MonitorCCJ · Traditional 01/14/2014SE
K121768CosenseCCJ · Traditional 10/31/2012SE

Questions and answers

When was CoSense ETCO Monitor cleared by the FDA?

CoSense ETCO Monitor (K151107) received a 510(k) decision of Substantially Equivalent on July 22, 2015, 86 days after the submission was received.

What is the product code of K151107?

The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.