510(k) K170439

AN87 Dosimeter by Andersen Sterilizers, Inc. — Product Code JOJ

K170439 is an FDA 510(k) premarket notification submitted by Andersen Sterilizers, Inc. for the device "AN87 Dosimeter". The FDA issued a decision of Substantially Equivalent on November 1, 2017. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Andersen Sterilizers, Inc. has at least 10 other 510(k) clearances on record.