The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Sandmill Rms.
| Device ID | K834512 |
| 510k Number | K834512 |
| Device Name: | SANDMILL RMS |
| Classification | Electrode, Ph, Stomach |
| Applicant | SANDHILL SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-02-21 |