510(k) K880378

LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 by Lifecare Services, Inc. — Product Code CCL

K880378 is an FDA 510(k) premarket notification submitted by Lifecare Services, Inc. for the device "LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001". The FDA issued a decision of Substantially Equivalent on September 30, 1988. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Lifecare Services, Inc. has at least 10 other 510(k) clearances on record.