510(k) K911453

OBTRASOUND STETHOSCOPE FETAL CALC by Medasonics, Inc. — Product Code KNG

K911453 is an FDA 510(k) premarket notification submitted by Medasonics, Inc. for the device "OBTRASOUND STETHOSCOPE FETAL CALC". The FDA issued a decision of Substantially Equivalent on June 20, 1991. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Medasonics, Inc. has at least 10 other 510(k) clearances on record.