The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 21hk512d.
| Device ID | K191864 |
| 510k Number | K191864 |
| Device Name: | 21HK512D |
| Classification | Display, Diagnostic Radiology |
| Applicant | LG Electronics Inc. 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-si, KR 17709 |
| Contact | Jinhwan Jun |
| Correspondent | Jinhwan Jun LG Electronics Inc. 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-si, KR 17709 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-12 |
| Decision Date | 2019-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00719192633070 | K191864 | 000 |