510(k) K192875

Philips Biosensor BX100 by Philips Medical Systems — Product Code DRG

K192875 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "Philips Biosensor BX100". The FDA issued a decision of Substantially Equivalent on April 16, 2020. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Philips Medical Systems has at least 10 other 510(k) clearances on record.