510(k) K920307
K920307 is an FDA 510(k) premarket notification submitted by Ausonics Pty , Ltd. for the device "AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION". The FDA issued a decision of Substantially Equivalent on May 19, 1992. 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
- May 19, 1992
- Date Received
- January 23, 1992
- 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