510(k) K862364

NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) by Swemed Laboratories, Inc. — Product Code HEM

K862364 is an FDA 510(k) premarket notification submitted by Swemed Laboratories, Inc. for the device "NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)". The FDA issued a decision of SN on August 19, 1986. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Swemed Laboratories, Inc. has at least 1 other 510(k) clearance on record.