510(k) K896038

B-SCAN 10 MHZ PROBE by Teknar, Inc. — Product Code ITX

K896038 is an FDA 510(k) premarket notification submitted by Teknar, Inc. for the device "B-SCAN 10 MHZ PROBE". The FDA issued a decision of Substantially Equivalent on April 23, 1990. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Teknar, Inc. has at least 10 other 510(k) clearances on record.