The following data is part of a premarket notification filed by Rf Medical Co., Ltd with the FDA for Mygen V-1000 Rf System.
| Device ID | K180999 |
| 510k Number | K180999 |
| Device Name: | Mygen V-1000 RF System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RF Medical Co., Ltd #502, 503, 506, 511, 254, Beotkkot-ro, Geumcheon-gu Seoul, KR |
| Contact | Kwang S. Choi |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809559960290 | K180999 | 000 |
| 08800142923777 | K180999 | 000 |
| 08800142923760 | K180999 | 000 |
| 08800142923753 | K180999 | 000 |
| 08800142923746 | K180999 | 000 |
| 08800142923739 | K180999 | 000 |
| 08800142923722 | K180999 | 000 |
| 08800142923715 | K180999 | 000 |
| 08800142923708 | K180999 | 000 |
| 08800142923784 | K180999 | 000 |
| 08800142923791 | K180999 | 000 |
| 08809559960306 | K180999 | 000 |
| 08809559960283 | K180999 | 000 |
| 08809559960139 | K180999 | 000 |
| 08809559960078 | K180999 | 000 |
| 08809559960061 | K180999 | 000 |
| 08809295147030 | K180999 | 000 |
| 08809559961419 | K180999 | 000 |
| 08800142923807 | K180999 | 000 |
| 08800142923692 | K180999 | 000 |