The following data is part of a premarket notification filed by Visura Technologies, Llc with the FDA for Visura Technologies Teecad System.
| Device ID | K180911 |
| 510k Number | K180911 |
| Device Name: | Visura Technologies TEECAD System |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | Visura Technologies, LLC 9337 Harding Avenue Evanston, IL 60203 |
| Contact | Eric Sandberg |
| Correspondent | Gina Correa Valleygrey Enterprise 396 N. Whisman Rd. Mountain View, CA 94043 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-06 |
| Decision Date | 2018-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860226002512 | K180911 | 000 |
| 00860226002505 | K180911 | 000 |
| 00860226002536 | K180911 | 000 |
| 00860226002529 | K180911 | 000 |