510(k) K171129

CO Check Pro, CO Screen by MD Diagnostics Limited — Product Code CCJ

K171129 is an FDA 510(k) premarket notification submitted by MD Diagnostics Limited for the device "CO Check Pro, CO Screen". The FDA issued a decision of Substantially Equivalent on March 2, 2018. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. MD Diagnostics Limited has at least 1 other 510(k) clearance on record.