The following data is part of a premarket notification filed by Lg Electronics with the FDA for Ashk100g.
| Device ID | K191188 |
| 510k Number | K191188 |
| Device Name: | ASHK100G |
| Classification | System, Image Processing, Radiological |
| Applicant | LG Electronics 222, Lg-ro, Cheongho-ri Jinwi-myeon Pyeongtaek-si, KR 17709 |
| Contact | Jinhwan Jun |
| Correspondent | Jinhwan Jun LG Electronics 222, Lg-ro, Cheongho-ri Jinwi-myeon Pyeongtaek-si, KR 17709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2019-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00719192635272 | K191188 | 000 |