Flexilog LS
FDA 510(k) K964804 · Oakfield Instruments, Ltd.
510(k) numberK964804
Submission
- Device name
- Flexilog LS
- Applicant
- Oakfield Instruments, Ltd.
Oxon Ox8 1ja England, GB - Received
- November 29, 1996
- Decision date
- August 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K964589 | Flexilog 3000KLA · Traditional | 03/04/1997SE |
| K961895 | Flexilog LS 13921KLA · Traditional | 11/04/1996SE |
| K945069 | Flexilog 2000FFT · Traditional | 06/13/1995SE |
| K920115 | MediscintIZD · Traditional | 03/30/1992SE |
| K902460 | Cardioscint (Left Ventricular Function Monitor)IZD · Traditional | 08/28/1990SE |
| K896288 | Flexilog 1010 Ambulatory PH Monitoring SystemFFT · Traditional | 05/04/1990SE |
| K894902 | SourcererJJJ · Traditional | 10/17/1989SE |
Questions and answers
When was Flexilog LS cleared by the FDA?
Flexilog LS (K964804) received a 510(k) decision of Substantially Equivalent on August 6, 1997, 250 days after the submission was received.
What is the product code of K964804?
The FDA product code is KLA – Monitor, Esophageal Motility, Anorectal Motility, And Tube, a Class II (moderate risk) device regulated under 21 CFR 876.1725.