Cosense Co Monitor

FDA 510(k) K130036 · Capnia, Inc.

Substantially Equivalent

510(k) numberK130036

Submission

Device name
Cosense Co Monitor
Applicant
Capnia, Inc.
Palo Alto, CA, US
Received
January 7, 2013
Decision date
January 14, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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K151107CoSense ETCO MonitorCCJ · Special Capnia, Inc.07/22/2015SE
K121768CosenseCCJ · Traditional Capnia, Inc.10/31/2012SE
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More from Fim Medical

510(k)DeviceDecision
K253119CoSense ETCO MonitorCCJ · Traditional 05/29/2026SE
K151107CoSense ETCO MonitorCCJ · Special 07/22/2015SE
K121768CosenseCCJ · Traditional 10/31/2012SE

Questions and answers

When was Cosense Co Monitor cleared by the FDA?

Cosense Co Monitor (K130036) received a 510(k) decision of Substantially Equivalent on January 14, 2014, 372 days after the submission was received.

What is the product code of K130036?

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