K834512 is an FDA 510(k) clearance for the SANDMILL RMS. This device is classified as a Electrode, Ph, Stomach (Class I — General Controls, product code FFT).
Submitted by Sandhill Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984, 62 days after receiving the submission on December 21, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K834512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | December 21, 1983 |
| Decision Date | February 21, 1984 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFT — Electrode, Ph, Stomach |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1400 |