510(k) K900155

INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER by Interspec, Inc. — Product Code ITX

K900155 is an FDA 510(k) premarket notification submitted by Interspec, Inc. for the device "INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER". The FDA issued a decision of Substantially Equivalent on October 5, 1990. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Interspec, Inc. has at least 10 other 510(k) clearances on record.