The following data is part of a premarket notification filed by Futrex, Inc. with the FDA for Futrex-6100/xl.
| Device ID | K963271 |
| 510k Number | K963271 |
| Device Name: | FUTREX-6100/XL |
| Classification | Analyzer, Body Composition |
| Applicant | FUTREX, INC. 6 MONTGOMERY VILLAGE AVE., SUITE 620 Gaithersburg, MD 20879 |
| Contact | Tori Tunnell |
| Correspondent | Tori Tunnell FUTREX, INC. 6 MONTGOMERY VILLAGE AVE., SUITE 620 Gaithersburg, MD 20879 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1998-08-19 |