510(k) K844184

D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB by D.R.G. — Product Code IYO

K844184 is an FDA 510(k) premarket notification submitted by D.R.G. for the device "D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB". The FDA issued a decision of Substantially Equivalent on September 6, 1985. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. D.R.G. has at least 1 other 510(k) clearance on record.