The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 14hq701g-b.
Device ID | K221394 |
510k Number | K221394 |
Device Name: | 14HQ701G-B |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | LG Electronics Inc. 77, Sanho-daero Gumi-si, KR 39381 |
Contact | Jinhwan Jun |
Correspondent | Woo Chai Kyoung GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, KR 03909 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-13 |
Decision Date | 2022-07-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00195174039458 | K221394 | 000 |