510(k) K083667

NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 by B-K Medical Aps — Product Code ITX

K083667 is an FDA 510(k) premarket notification submitted by B-K Medical Aps for the device "NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337". The FDA issued a decision of Substantially Equivalent on Feb 2, 2009. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. B-K Medical Aps has 10 other 510(k) clearances on record.