The following data is part of a premarket notification filed by Mediana Co., Ltd with the FDA for V10.
| Device ID | K152659 |
| 510k Number | K152659 |
| 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 Consultants, LLC 12226 Washington Lane Echo, OR 97826 |
| 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 | 2015-09-17 |
| Decision Date | 2016-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800003447494 | K152659 | 000 |
| 18800003447487 | K152659 | 000 |
| 18800003447470 | K152659 | 000 |
| 18800003424990 | K152659 | 000 |
| 18800003424952 | K152659 | 000 |
| 18800003424808 | K152659 | 000 |
| 18800003424792 | K152659 | 000 |
| 18800003424761 | K152659 | 000 |
| 18800003424754 | K152659 | 000 |