510(k) K896427

SPACELABS' MODEL 90514, MULTIGAS ANALYZER by Spacelabs, Inc. — Product Code CCL

K896427 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "SPACELABS' MODEL 90514, MULTIGAS ANALYZER". The FDA issued a decision of Substantially Equivalent on January 24, 1990. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.