The following data is part of a premarket notification filed by Sti Medical Systems, Llc with the FDA for Ultrasighthd C31 With Imagesense And Remote Viewer Telemedicine.
| Device ID | K110147 |
| 510k Number | K110147 |
| Device Name: | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | STI MEDICAL SYSTEMS, LLC 4275 EXECUTIVE SQUARE, SUITE 825 La Jolla, CA 92037 |
| Contact | Rolf Wolters |
| Correspondent | Rolf Wolters STI MEDICAL SYSTEMS, LLC 4275 EXECUTIVE SQUARE, SUITE 825 La Jolla, CA 92037 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-04-08 |
| Summary: | summary |