The following data is part of a premarket notification filed by Oakfield Instruments, Ltd. with the FDA for Flexilog Ls.
| Device ID | K964804 |
| 510k Number | K964804 |
| Device Name: | FLEXILOG LS |
| Classification | Monitor, Esophageal Motility, And Tube |
| 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 | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-08-06 |
| Summary: | summary |