The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for V10.
| Device ID | K170497 |
| 510k Number | K170497 |
| Device Name: | V10 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup Wonju-si, KR 220-801 |
| Contact | Kim Min-hye |
| Correspondent | Charlie Mack International Regulatory Consulatants 7808 Rush Creek Drive Pasco, WA 99301 |
| Product Code | DXN |
| Subsequent Product Code | DQA |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800003439444 | K170497 | 000 |
| 18800003456809 | K170497 | 000 |
| 18800003407740 | K170497 | 000 |
| 18800003407757 | K170497 | 000 |
| 18800003407788 | K170497 | 000 |
| 18800003407795 | K170497 | 000 |
| 18800003408488 | K170497 | 000 |
| 18800003408495 | K170497 | 000 |
| 18800003408686 | K170497 | 000 |
| 18800003408693 | K170497 | 000 |
| 18800003408884 | K170497 | 000 |
| 18800003408891 | K170497 | 000 |
| 18800003439420 | K170497 | 000 |
| 18800003439437 | K170497 | 000 |
| 18800003456847 | K170497 | 000 |