The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Evs 4343w / Evs 4343wg / Evs 4343wp / Evs 3643w / Evs 3643wg / Evs 3643wp.
| Device ID | K193017 |
| 510k Number | K193017 |
| Device Name: | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si, KR 13216 |
| Contact | Shin Dongwook |
| Correspondent | Shin Dongwook DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si, KR 13216 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-29 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018406502 | K193017 | 000 |
| 08800018406106 | K193017 | 000 |
| 08800018406007 | K193017 | 000 |
| 08800018405901 | K193017 | 000 |
| 08800018405802 | K193017 | 000 |
| 08800018406403 | K193017 | 000 |