K013951 is an FDA 510(k) clearance for the SANDHILL SCIENTIFIC PEDIATEC PH PROBE, a Electrode, Ph, Stomach (Class I — General Controls, product code FFT), submitted by Sandhill Scientific, Inc. (Boulder, US). The FDA issued a Cleared decision on February 28, 2002, 90 days after receiving the submission on November 30, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K013951 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 30, 2001 |
| Decision Date | February 28, 2002 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFT — Electrode, Ph, Stomach |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1400 |