The following data is part of a premarket notification filed by Tanita Corp. with the FDA for Model Mc-180ma Multi-frequency Body Composition Analyzer.
| Device ID | K100183 |
| 510k Number | K100183 |
| Device Name: | MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | TANITA CORP. 2625 SOUTH CLEARBROOK DRIVE Arlington Heights, IL 60005 |
| Contact | Toshishiko Ishikawa |
| Correspondent | Toshishiko Ishikawa TANITA CORP. 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 | 2010-01-21 |
| Decision Date | 2011-04-15 |
| Summary: | summary |