The following data is part of a premarket notification filed by Tanita Corporation Of America with the FDA for Innerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor.
| Device ID | K062652 |
| 510k Number | K062652 |
| Device Name: | INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR |
| Classification | Analyzer, Body Composition |
| Applicant | TANITA CORPORATION OF AMERICA 2625 SOUTH CLEARBROOK DRIVE Arlington Heights, IL 60005 |
| Contact | Beth Mackey |
| Correspondent | Beth Mackey TANITA CORPORATION OF AMERICA 2625 SOUTH CLEARBROOK DRIVE Arlington Heights, IL 60005 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-07 |
| Decision Date | 2006-12-28 |
| Summary: | summary |