510(k) K921863

SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS by Hewlett-Packard Co. — Product Code GXW

K921863 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS". The FDA issued a decision of Substantially Equivalent on September 28, 1992. The device falls under product code GXW (Echoencephalograph), a Class II device regulated under 21 CFR 882.1240. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.