K945069 is an FDA 510(k) clearance for the FLEXILOG 2000, a Electrode, Ph, Stomach (Class I — General Controls, product code FFT), submitted by Oakfield Instruments, Ltd. (Oxon Ox8 1ja England, GB). The FDA issued a Cleared decision on June 13, 1995, 242 days after receiving the submission on October 14, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K945069 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 14, 1994 |
| Decision Date | June 13, 1995 |
| Days to Decision | 242 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 |