510(k) K900271

MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK by Digisonics, Inc. — Product Code HEM

K900271 is an FDA 510(k) premarket notification submitted by Digisonics, Inc. for the device "MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK". The FDA issued a decision of Substantially Equivalent on April 19, 1990. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Digisonics, Inc. has at least 2 other 510(k) clearances on record.