510(k) K162007

STERRAD NX Sterilizer by Advanced Sterilization Products — Product Code MLR

K162007 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD NX Sterilizer". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.