K955018 is an FDA 510(k) clearance for the TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR, a Electrode, Ph, Stomach (Class I — General Controls, product code FFT), submitted by Instrumentarium Corp. (Boston, US). The FDA issued a Cleared decision on January 30, 1996, 89 days after receiving the submission on November 2, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K955018 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 1995 |
| Decision Date | January 30, 1996 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FFT — Electrode, Ph, Stomach |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1400 |