The following data is part of a premarket notification filed by Tractus Corporation with the FDA for Tractus Tissuemapper Image Recording System Application.
| Device ID | K131489 |
| 510k Number | K131489 |
| Device Name: | TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TRACTUS CORPORATION 1394 25TH ST. NW Buffalo, MN 55313 |
| Contact | Mark Job |
| 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 | 2013-05-23 |
| Decision Date | 2013-06-25 |
| Summary: | summary |