The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 21hq613d.
Device ID | K221061 |
510k Number | K221061 |
Device Name: | 21HQ613D |
Classification | Display, Diagnostic Radiology |
Applicant | LG Electronics Inc. 77, Sanho-daero Gumi-si, KR 39381 |
Contact | Jinhwan Jun |
Correspondent | JongHyun Kim 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 | 2022-04-11 |
Decision Date | 2022-06-03 |