510(k) K053599

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES by Spacelabs Medical, Inc. — Product Code CBR

K053599 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 19, 2006. The device falls under product code CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1700. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.