The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Smartdop Xt6.
| Device ID | K153762 |
| 510k Number | K153762 |
| Device Name: | Smartdop XT6 |
| Classification | Transducer, Ultrasonic |
| Applicant | KOVEN TECHNOLOGY, INC. 12125 WOODCREST EXECUTIVE DR SUITE 320 St Louis, MO 63141 |
| Contact | Heather Bell |
| Correspondent | Heather Bell KOVEN TECHNOLOGY, INC. 12125 WOODCREST EXECUTIVE DR SUITE 320 St Louis, MO 63141 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-30 |
| Decision Date | 2016-05-25 |
| Summary: | summary |