The following data is part of a premarket notification filed by Lg Electronics with the FDA for 17hk700g-w.
Device ID | K180332 |
510k Number | K180332 |
Device Name: | 17HK700G-W |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | LG Electronics 222, Lg-ro, Cheongho-ri Jinwi-myeon Pyeongtaek-si, KR 17709 |
Contact | Jinhwan Jun |
Correspondent | Jinhwan Jun LG Electronics 222, Lg-ro, Cheongho-ri 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 | 2018-02-06 |
Decision Date | 2018-06-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00719192620766 | K180332 | 000 |
00719192633131 | K180332 | 000 |