The following data is part of a premarket notification filed by Signostics Pty Ltd with the FDA for Speqrt Ultrasound System.
| Device ID | K130659 |
| 510k Number | K130659 |
| Device Name: | SPEQRT ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIGNOSTICS PTY LTD LOT 1, 40-46 WEST THEBARTON RD Thebarton Sa, AU 5031 |
| Contact | Varda Swery |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-04-03 |
| Summary: | summary |