The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Smartdop Xt.
| Device ID | K131623 |
| 510k Number | K131623 |
| Device Name: | SMARTDOP XT |
| Classification | Transducer, Ultrasonic |
| Applicant | KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Contact | Harvey Knauss |
| Correspondent | Harvey Knauss KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2014-01-17 |
| Summary: | summary |