CO Check Pro, CO Screen
K-Number: K171129 · 2018-03-02
ApplicantMD Diagnostics Limited
Decision Date2018-03-02
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
CO Check Pro, CO Screen is a medical device manufactured by MD Diagnostics Limited. It received FDA 510(k) clearance on 2018-03-02 under approval number K171129. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CO Check Pro, CO Screen?
CO Check Pro, CO Screen is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by MD Diagnostics Limited. The 510(k) number is K171129.
When was CO Check Pro, CO Screen approved by the FDA?
CO Check Pro, CO Screen received FDA 510(k) clearance on 2018-03-02, under approval number K171129.
What company makes CO Check Pro, CO Screen?
CO Check Pro, CO Screen is manufactured by MD Diagnostics Limited.
What is the FDA product code for CO Check Pro, CO Screen?
The FDA product code for CO Check Pro, CO Screen is CCJ.
Other Devices by MD Diagnostics Limited
Related Devices (Code: CCJ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.