The following data is part of a premarket notification filed by Signostics Pty Ltd with the FDA for Speq Ultrasound System.
| Device ID | K090505 |
| 510k Number | K090505 |
| Device Name: | SPEQ ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SIGNOSTICS PTY LTD 13221 NE TEEM LOOP ROAD Bainbridge Island, WA 98110 |
| Contact | Charles F Hottinger |
| Correspondent | Charles F Hottinger SIGNOSTICS PTY LTD 13221 NE TEEM LOOP ROAD Bainbridge Island, WA 98110 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-26 |
| Decision Date | 2009-05-07 |
| Summary: | summary |