FDA 510(k)

Capnograph and Oximeter

K-Number: K170820 · 2018-07-18

Decision Date2018-07-18

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Capnograph and Oximeter is a medical device manufactured by Cmi Health, Inc.. It received FDA 510(k) clearance on 2018-07-18 under approval number K170820. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capnograph and Oximeter?

Capnograph and Oximeter is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Cmi Health, Inc.. The 510(k) number is K170820.

When was Capnograph and Oximeter approved by the FDA?

Capnograph and Oximeter received FDA 510(k) clearance on 2018-07-18, under approval number K170820.

What company makes Capnograph and Oximeter?

Capnograph and Oximeter is manufactured by Cmi Health, Inc..

What is the FDA product code for Capnograph and Oximeter?

The FDA product code for Capnograph and Oximeter is CCK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.