The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Insight Sphincter Of Oddi Manometry Module, Model S981300.
| Device ID | K990441 |
| 510k Number | K990441 |
| Device Name: | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-11 |
| Decision Date | 1999-05-12 |
| Summary: | summary |