510(k) K871337

M-2 OXYGEN/TEMPERATURE MONITOR by Bio-Med Devices, Inc. — Product Code CCL

K871337 is an FDA 510(k) premarket notification submitted by Bio-Med Devices, Inc. for the device "M-2 OXYGEN/TEMPERATURE MONITOR". The FDA issued a decision of Substantially Equivalent on June 5, 1987. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Bio-Med Devices, Inc. has at least 10 other 510(k) clearances on record.