The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Sandhill Unitip Catheter Pressure Sensor, Model K 5251-l3-0026.
| Device ID | K002427 |
| 510k Number | K002427 |
| Device Name: | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | SANDHILL SCIENTIFIC, INC. 9150 COMMERCE CENTER CIR.,#500 Highlands Ranch, CO 80129 |
| Contact | Liunda L Diederich |
| Correspondent | Liunda L Diederich SANDHILL SCIENTIFIC, INC. 9150 COMMERCE CENTER CIR.,#500 Highlands Ranch, CO 80129 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2001-06-22 |