510(k) K851358

MODEL BION 2/TYPE 90 ROOM IONIZER by Medicor USA , Ltd. — Product Code FRF

K851358 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "MODEL BION 2/TYPE 90 ROOM IONIZER". The FDA issued a decision of Substantially Equivalent on July 1, 1985. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.