510(k) K902190

FETAL PULSE DETECTOR MODEL DOP-1 by Advanced Medical Systems, Inc. — Product Code HEK

K902190 is an FDA 510(k) premarket notification submitted by Advanced Medical Systems, Inc. for the device "FETAL PULSE DETECTOR MODEL DOP-1". The FDA issued a decision of Substantially Equivalent on October 22, 1990. The device falls under product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Advanced Medical Systems, Inc. has at least 9 other 510(k) clearances on record.