510(k) K093308

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD by Nidek Medical Products, Inc. — Product Code CAW

K093308 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD". The FDA issued a decision of Substantially Equivalent on January 14, 2010. 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.