The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Insight Gastrointestinal Motility System, Model S980000.
| Device ID | K984444 |
| 510k Number | K984444 |
| Device Name: | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | SANDHILL SCIENTIFIC, INC. 8955 SOUTH RIDGELINE BLVD., UNIT #500 Highlands Ranch, CO 80126 |
| Contact | Linda L Diederich |
| Correspondent | Linda L Diederich SANDHILL SCIENTIFIC, INC. 8955 SOUTH RIDGELINE BLVD., UNIT #500 Highlands Ranch, CO 80126 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-01-11 |
| Summary: | summary |