510(k) K800271

COROMETRICS MEDICAL SYSTEMS 220 PH SYS. by Transidyne General Corp. — Product Code CHL

K800271 is an FDA 510(k) premarket notification submitted by Transidyne General Corp. for the device "COROMETRICS MEDICAL SYSTEMS 220 PH SYS.". The FDA issued a decision of Substantially Equivalent on February 26, 1980. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Transidyne General Corp. has at least 10 other 510(k) clearances on record.