Sandhill Scientific, Inc.

Medical device manufacturer in Boulder, CO.

16510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K111013AcemFFZ · Traditional 12/19/2011SE
K012232Insight, Model S980000FFX · Traditional 06/07/2002SE
K013951Sandhill Scientific Pediatec PH ProbeFFT · Traditional 02/28/2002SE
K002427Sandhill Unitip Catheter Pressure Sensor, Model K 5251-L3-0026FFX · Abbreviated 06/22/2001SE
K990441Insight Sphincter of Oddi Manometry Module, Model S981300FFX · Traditional 05/12/1999SE
K984444Insight Gastrointestinal Motility System, Model S980000FFX · Special 01/11/1999SE
K961056Bioview Model S960000KLA · Traditional 06/06/1996SE
K942247Small Bowel Analysis SoftwareFFX · Traditional 04/09/1996SE
K941801AnalgraphKLA · Traditional 09/08/1995SE
K931963Sandhill Disposable Internal Reference PH ProbeFFT · Traditional 09/28/1994SE
K926218Eisman-Tries Mep (Multiple Electrode Probe)HIR · Traditional 08/26/1994SE
K932306MicroinfusorFFX · Traditional 04/01/1994SE
K931175Schuster Disposable Balloon ProbeFAP · Traditional 04/01/1994SE
K912772SuperloggerFFT · Traditional 02/07/1992SE
K904231Model Osp, Sandhill AmsFAD · Traditional 01/02/1991SE
K834512Sandmill RMSFFT · Traditional 02/21/1984SE

Recalls

RecallProductInitiated
Z-1487-2012 Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use…Software error may produce incorrect esophageal contraction readings. 02/23/2009Terminated