The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Ausonics Opus 1 System, Annular Array Option.
| Device ID | K920307 |
| 510k Number | K920307 |
| Device Name: | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | AUSONICS PTY LTD. 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Richard S Morey |
| Correspondent | Richard S Morey AUSONICS PTY LTD. 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-23 |
| Decision Date | 1992-05-19 |