510(k) K860494

7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T by Ausonics Pty , Ltd. — Product Code ITX

K860494 is an FDA 510(k) premarket notification submitted by Ausonics Pty , Ltd. for the device "7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T". The FDA issued a decision of Substantially Equivalent on March 26, 1986. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Ausonics Pty , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1986
Date Received
February 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type