Zinetics Composite Sensor Probe W/Internal Ref.
FDA 510(k) K925405 · Synectics-Dantec
510(k) numberK925405
Submission
- Device name
- Zinetics Composite Sensor Probe W/Internal Ref.
- Applicant
- Synectics-Dantec
Irving, TX, US - Received
- October 26, 1992
- Decision date
- September 30, 1994
- 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
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| K945069 | Flexilog 2000FFT · Traditional | Oakfield Instruments, Ltd. | 06/13/1995SE |
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| K934434 | Cyberrx Model 7200FFT · Traditional | Cybermed Control Systems, Inc. | 01/24/1995SE |
| K931963 | Sandhill Disposable Internal Reference PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 09/28/1994SE |
More from Sandhill Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961346 | PH Analysis ModuleFFT · Traditional | 01/29/1997SE |
| K924875 | Microtrapper/Microdigitrapper, Add ModificationsBZQ · Traditional | 06/30/1994ST |
| K914793 | Monocrystant Ph/Les Catheter, ModificationKLA · Traditional | 12/13/1993SE |
| K924383 | Synectics Liberty System, PC Polygraf/Polygram UroFAP · Traditional | 06/18/1993SE |
| K913817 | Monocrystant Ph-Reference Catheter, ModificationFFT · Traditional | 06/11/1992SE |
| K914624 | PH Meter, ModificationFFT · Traditional | 04/28/1992SE |
| K914219 | Airway ThermistorBZG · Traditional | 02/26/1992SE |
| K913387 | Digitrapper Mark IIIFFT · Traditional | 12/27/1991SE |
| K904625 | Synectics Liberty System, PC Polygraf and PolygramBZG · Traditional | 08/20/1991SE |
| K905520 | Microtrapper/Microdigitrapper, ModificationBZQ · Traditional | 04/26/1991SE |
Questions and answers
When was Zinetics Composite Sensor Probe W/Internal Ref. cleared by the FDA?
Zinetics Composite Sensor Probe W/Internal Ref. (K925405) received a 510(k) decision of Substantially Equivalent on September 30, 1994, 704 days after the submission was received.
What is the product code of K925405?
The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.