510(k) K073593

I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 by Deltex Medical Limited — Product Code DPT

K073593 is an FDA 510(k) premarket notification submitted by Deltex Medical Limited for the device "I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016". The FDA issued a decision of Substantially Equivalent on January 29, 2009. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Deltex Medical Limited has at least 5 other 510(k) clearances on record.