K964589 is an FDA 510(k) clearance for the FLEXILOG 3000. This device is classified as a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II — Special Controls, product code KLA).
Submitted by Oakfield Instruments, Ltd. (Oxon Ox8 1ja England, GB). The FDA issued a Cleared decision on March 4, 1997, 109 days after receiving the submission on November 15, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K964589 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 1996 |
| Decision Date | March 04, 1997 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KLA — Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1725 |