Flexilog 2000
FDA 510(k) K945069 · Oakfield Instruments, Ltd.
510(k) numberK945069
Submission
- Device name
- Flexilog 2000
- Applicant
- Oakfield Instruments, Ltd.
Oxon Ox8 1ja England, GB - Received
- October 14, 1994
- Decision date
- June 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFT – Electrode, Ph, Stomach
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1400
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102543 | Bravo PH Monitoring System and AccessoriesFFT · Traditional | Given Imaging , Ltd. | 12/01/2010SE |
| K013951 | Sandhill Scientific Pediatec PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 02/28/2002SE |
| K002028 | Bravo PH Monitoring SystemFFT · Traditional | Endonetics, Inc. | 09/29/2000SE |
| K961346 | PH Analysis ModuleFFT · Traditional | Synectics-Dantec | 01/29/1997SE |
| K950087 | Lot 440FFT · Traditional | Medical Instruments Corporation Mic AG | 02/06/1996SE |
| K955018 | Trip NGS & Sigmoid Catheter Phi Slide CalculatorFFT · Traditional | Instrumentarium Corp. | 01/30/1996SE |
| K920849 | Trip Cic CatheterFFT · Traditional | Tonometrics, Inc. | 03/17/1995SE |
| K934434 | Cyberrx Model 7200FFT · Traditional | Cybermed Control Systems, Inc. | 01/24/1995SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | Synectics-Dantec | 09/30/1994SE |
| K931963 | Sandhill Disposable Internal Reference PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 09/28/1994SE |
More from Sandhill Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964804 | Flexilog LSKLA · Traditional | 08/06/1997SE |
| K964589 | Flexilog 3000KLA · Traditional | 03/04/1997SE |
| K961895 | Flexilog LS 13921KLA · Traditional | 11/04/1996SE |
| 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 2000 cleared by the FDA?
Flexilog 2000 (K945069) received a 510(k) decision of Substantially Equivalent on June 13, 1995, 242 days after the submission was received.
What is the product code of K945069?
The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.