510(k) K031733

NON-CONTACT TONOMETER, MODEL NT-4000 by Nidek, Inc. — Product Code HKX

K031733 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NON-CONTACT TONOMETER, MODEL NT-4000". The FDA issued a decision of Substantially Equivalent on December 4, 2003. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Nidek, Inc. has at least 10 other 510(k) clearances on record.