The following data is part of a premarket notification filed by Biospace Corporation Limited with the FDA for Inbody, Models: 270, R20, R20b.
Device ID | K092786 |
510k Number | K092786 |
Device Name: | INBODY, MODELS: 270, R20, R20B |
Classification | Analyzer, Body Composition |
Applicant | BIOSPACE CORPORATION LIMITED 8726 FERRARA CT. Naples, FL 34114 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm BIOSPACE CORPORATION LIMITED 8726 FERRARA CT. Naples, FL 34114 |
Product Code | MNW |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-10 |
Decision Date | 2010-03-10 |
Summary: | summary |