510(k) K880900

SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER by Corometrics Medical Systems, Inc. — Product Code HEM

K880900 is an FDA 510(k) premarket notification submitted by Corometrics Medical Systems, Inc. for the device "SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Corometrics Medical Systems, Inc. has at least 4 other 510(k) clearances on record.