The following data is part of a premarket notification filed by Sentiar, Inc with the FDA for Sentep.
| Device ID | K192890 |
| 510k Number | K192890 |
| Device Name: | SentEP |
| Classification | System, Image Processing, Radiological |
| Applicant | SentiAR, Inc 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis, MO 63108 |
| Contact | Berk Tas |
| Correspondent | Berk Tas SentiAR, Inc 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis, MO 63108 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-10 |
| Decision Date | 2020-09-18 |