The following data is part of a premarket notification filed by Lg Electronics Inc. with the FDA for 14hk701g-w.
| Device ID | K182348 |
| 510k Number | K182348 |
| Device Name: | 14HK701G-W |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | LG Electronics Inc. 222, LG-Ro Jinwi-myeon Pyeongtaek-si, KR 17709 |
| Contact | Jinhwan Jun |
| Correspondent | Jinhwan Jun LG Electronics Inc. 222, LG-Ro Jinwi-myeon Pyeongtaek-si, KR 17709 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-29 |
| Decision Date | 2018-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00719192620759 | K182348 | 000 |
| 00719192633124 | K182348 | 000 |