The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Doppler Upgrade For Ausonics Opus 1 Real Time Scan.
| Device ID | K905488 |
| 510k Number | K905488 |
| Device Name: | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | AUSONICS PTY LTD. 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Richard Morey |
| Correspondent | Richard Morey AUSONICS PTY LTD. 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1991-12-18 |