510(k) K994346

ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM by Sendx Medical, Inc. — Product Code CHL

K994346 is an FDA 510(k) premarket notification submitted by Sendx Medical, Inc. for the device "ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 2000. 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. Sendx Medical, Inc. has at least 5 other 510(k) clearances on record.