The following data is part of a premarket notification filed by Futrex, Inc. with the FDA for Futrex-5000a.
| Device ID | K922601 |
| 510k Number | K922601 |
| Device Name: | FUTREX-5000A |
| Classification | Plethysmograph, Impedance |
| Applicant | FUTREX, INC. P.O. BOX 2398 Gaithersburg, MD 20886 |
| Contact | Jonathan S Forest |
| Correspondent | Jonathan S Forest FUTREX, INC. P.O. BOX 2398 Gaithersburg, MD 20886 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-02 |
| Decision Date | 1995-12-28 |