510(k) K023024

TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 by Vascular Control Systems, Inc. — Product Code ITX

K023024 is an FDA 510(k) premarket notification submitted by Vascular Control Systems, Inc. for the device "TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02". The FDA issued a decision of Substantially Equivalent on September 26, 2002. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Vascular Control Systems, Inc. has at least 8 other 510(k) clearances on record.