510(k) K953831

N 800 HF by Nucletron-Oldelft Corp. — Product Code IZO

K953831 is an FDA 510(k) premarket notification submitted by Nucletron-Oldelft Corp. for the device "N 800 HF". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Nucletron-Oldelft Corp. has at least 10 other 510(k) clearances on record.