The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Evs 4343a, Evs 4343ag, Evs 3643a, Evs 3643ag.
| Device ID | K192400 |
| 510k Number | K192400 |
| Device Name: | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG |
| 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 | Choul-woo Shin |
| Correspondent | Choul-woo Shin 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 | 2019-09-03 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018405703 | K192400 | 000 |
| 08800018405604 | K192400 | 000 |
| 08800018405505 | K192400 | 000 |
| 08800018405406 | K192400 | 000 |