The following data is part of a premarket notification filed by Signostics Ltd with the FDA for Signosrt Bladder Ultrasound System.
| Device ID | K143493 |
| 510k Number | K143493 |
| Device Name: | SignosRT Bladder Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Signostics Ltd 1284 South Road, Clovelly Park Pasadena, AU Sa 5042 |
| Contact | Stewart Bartlett |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-12-09 |
| Decision Date | 2015-01-14 |
| Summary: | summary |