K896288 is an FDA 510(k) clearance for the FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM. This device is classified as 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 May 4, 1990, 186 days after receiving the submission on October 30, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K896288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 1989 |
| Decision Date | May 04, 1990 |
| Days to Decision | 186 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 |