Modified Proxima Monitor/Digitrapper Ed Unit
FDA 510(k) K902366 · Synectics-Dantec
510(k) numberK902366
Submission
- Device name
- Modified Proxima Monitor/Digitrapper Ed Unit
- Applicant
- Synectics-Dantec
Irving, TX, US - Received
- May 16, 1990
- Decision date
- June 8, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K945069 | Flexilog 2000FFT · Traditional | Oakfield Instruments, Ltd. | 06/13/1995SE |
| 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 |
More from Synectics-Dantec
| 510(k) | Device | Decision |
|---|---|---|
| K961346 | PH Analysis ModuleFFT · Traditional | 01/29/1997SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | 09/30/1994SE |
| 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 |
Questions and answers
When was Modified Proxima Monitor/Digitrapper Ed Unit cleared by the FDA?
Modified Proxima Monitor/Digitrapper Ed Unit (K902366) received a 510(k) decision of Substantially Equivalent on June 8, 1990, 23 days after the submission was received.
What is the product code of K902366?
The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.