The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for V20, V20a, Avsm3 Snf.
| Device ID | K200434 |
| 510k Number | K200434 |
| Device Name: | V20, V20a, AVSM3 SNF |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup Wonju-si, KR 26365 |
| Contact | Dana Mun |
| Correspondent | Charlie Mack International Regulatory Consultants 2950 E Lindrick Drive Chandler, AZ 85249 |
| 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 | 2020-02-24 |
| Decision Date | 2020-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800003460066 | K200434 | 000 |
| 18800003465528 | K200434 | 000 |
| 18800003465535 | K200434 | 000 |