510(k) K891674

NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 by Preemicare Corp. — Product Code CCL

K891674 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "NEONATAL ENVIRONMENTAL MONITOR, MODEL 275". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Preemicare Corp. has at least 8 other 510(k) clearances on record.