510(k) K040892

MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 by Nidek Medical Products, Inc. — Product Code CAW

K040892 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905". The FDA issued a decision of Substantially Equivalent on April 29, 2004. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Nidek Medical Products, Inc. has at least 10 other 510(k) clearances on record.