510(k) K931963 ยท FFT Electrode, Ph, Stomach
SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
| Applicant | Sandhill Scientific, Inc., Littleton CO, US |
| Decision | Substantially Equivalent, Sep 28, 1994 |
| Received | Apr 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2003 | Sandhill Scientific, Inc ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system Terminated |
FFT | None listed |
| Jan 23, 2003 | Sandhill Scientific, Inc ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually. Terminated |
FFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.