The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 21hq513d.
| Device ID | K212295 |
| 510k Number | K212295 |
| Device Name: | 21HQ513D |
| Classification | Display, Diagnostic Radiology |
| Applicant | LG Electronics Inc. 77, Sanho-daero Gumi-si, KR 39381 |
| Contact | Jinhwan Jun |
| Correspondent | Dogyun Im GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, KR 03909 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-22 |
| Decision Date | 2021-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195174017296 | K212295 | 000 |
| 00195174091678 | K212295 | 000 |