The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Siemens Neuroton 826 And 827.
| Device ID | K875238 |
| 510k Number | K875238 |
| Device Name: | SIEMENS NEUROTON 826 AND 827 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Contact | Karl Hausner |
| Correspondent | Karl Hausner ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-03-10 |