510(k) K123738

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

K123738 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD". The FDA issued a decision of Substantially Equivalent on February 28, 2013. 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.