The following data is part of a premarket notification filed by Oakfield Instruments, Ltd. with the FDA for Flexilog 1010 Ambulatory Ph Monitoring System.
| Device ID | K896288 |
| 510k Number | K896288 |
| Device Name: | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM |
| Classification | Electrode, Ph, Stomach |
| Applicant | OAKFIELD INSTRUMENTS, LTD. OAKFIELD INDUSTRIAL ESTATE STANTON HARCOURT RD, EYNSHAM Oxon Ox8 1ja England, GB |
| Contact | John Giddings |
| Correspondent | John Giddings OAKFIELD INSTRUMENTS, LTD. OAKFIELD INDUSTRIAL ESTATE STANTON HARCOURT RD, EYNSHAM Oxon Ox8 1ja England, GB |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1990-05-04 |