510(k) K944654

OXYGEN CONCENTRATION INDICATOR by Aequitron Medical, Inc. — Product Code CCL

K944654 is an FDA 510(k) premarket notification submitted by Aequitron Medical, Inc. for the device "OXYGEN CONCENTRATION INDICATOR". The FDA issued a decision of Substantially Equivalent on November 8, 1994. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Aequitron Medical, Inc. has at least 10 other 510(k) clearances on record.