510(k) K944597

GRAHAM-FIELD ULTRASOUND SCANNING GEL by Chester Labs, Inc. — Product Code IYO

K944597 is an FDA 510(k) premarket notification submitted by Chester Labs, Inc. for the device "GRAHAM-FIELD ULTRASOUND SCANNING GEL". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Chester Labs, Inc. has at least 10 other 510(k) clearances on record.