The following data is part of a premarket notification filed by Telemed with the FDA for Smartus Ext-1m/3m.
| Device ID | K163121 |
| 510k Number | K163121 |
| Device Name: | SmartUs EXT-1M/3M |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TELEMED DARIAUS IR GIRENO STR.42 Vilnius, LT Lt-02189 |
| Contact | Yury Sokolov |
| Correspondent | Yury Sokolov TELEMED DARIAUS IR GIRENO STR.42 Vilnius, LT Lt-02189 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04772057000246 | K163121 | 000 |
| 04772057000239 | K163121 | 000 |
| 04772057000222 | K163121 | 000 |
| 04772057000208 | K163121 | 000 |
| 04772057000192 | K163121 | 000 |
| 04772057000178 | K163121 | 000 |
| 04772057000161 | K163121 | 000 |
| 04772057000154 | K163121 | 000 |