510(k) K082566

MARK 5 NUVO LITE OCSI AND STD by Nidek Medical Products, Inc. — Product Code CAW

K082566 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "MARK 5 NUVO LITE OCSI AND STD". The FDA issued a decision of Substantially Equivalent on December 3, 2008. 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.