The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Wrist Blood Pressure Monitor & Fat Meter, Model Wt-20.
| Device ID | K031582 |
| 510k Number | K031582 |
| Device Name: | WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 |
| Classification | Analyzer, Body Composition |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm NIHON SEIMITSU SOKKI CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-08-01 |
| Summary: | summary |