Ambul. PH & Motility Recorder for Measure of Para.
FDA 510(k) K880581 · Synectics-Dantec
510(k) numberK880581
Submission
- Device name
- Ambul. PH & Motility Recorder for Measure of Para.
- Applicant
- Synectics-Dantec
Irving, TX, US - Received
- February 10, 1988
- Decision date
- August 11, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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More from Crospon, Ltd.
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|---|---|---|
| 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 Ambul. PH & Motility Recorder for Measure of Para. cleared by the FDA?
Ambul. PH & Motility Recorder for Measure of Para. (K880581) received a 510(k) decision of Substantially Equivalent on August 11, 1988, 183 days after the submission was received.
What is the product code of K880581?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.