510(k) K942593

OXYCHEK OXYGEN ANALYZER by Nidek Medical Products, Inc. — Product Code CCL

K942593 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "OXYCHEK OXYGEN ANALYZER". The FDA issued a decision of Substantially Equivalent on May 3, 1995. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Nidek Medical Products, Inc. has at least 10 other 510(k) clearances on record.