The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Small Bowel Analysis Software.
| Device ID | K942247 |
| 510k Number | K942247 |
| Device Name: | SMALL BOWEL ANALYSIS SOFTWARE |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
| Contact | Linda L Diederich |
| Correspondent | Linda L Diederich SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-09 |
| Decision Date | 1996-04-09 |
| Summary: | summary |