The following data is part of a premarket notification filed by Inbody Co. Ltd. with the FDA for Inbody.
Device ID | K200560 |
510k Number | K200560 |
Device Name: | InBody |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | InBody Co. Ltd. InBody Bldg., 625, Eonju-ro, Gangnam-gu Seoul, KR 06106 |
Contact | Koeun Jung |
Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-04 |
Decision Date | 2021-01-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809209590822 | K200560 | 000 |
08809209590815 | K200560 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INBODY 86918373 5546337 Live/Registered |
InBody Co., Ltd. 2016-02-24 |
INBODY 85447575 4160606 Live/Registered |
INBODY CO., LTD. 2011-10-14 |
INBODY 76165230 2815341 Dead/Cancelled |
BIOSPACE CO., LTD. 2000-11-13 |