The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Econsole1.
| Device ID | K152172 |
| 510k Number | K152172 |
| Device Name: | Econsole1 |
| Classification | System, Image Processing, Radiological |
| Applicant | DRTECH CORPORATION SUITE NO.2, 3 FLOOR, 29, DUNCHON-DAERO541BEON-GIL, JUNGWON-GU Seongnam-si, KR 462-807 |
| Contact | Choul-woo Shin |
| Correspondent | Choul-woo Shin DRTECH CORPORATION SUITE NO.2, 3 FLOOR, 29, DUNCHON-DAERO541BEON-GIL, JUNGWON-GU Seongnam-si, KR 462-807 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-04 |
| Decision Date | 2015-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018410004 | K152172 | 000 |