The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Bioview Model S960000.
| Device ID | K961056 |
| 510k Number | K961056 |
| Device Name: | BIOVIEW MODEL S960000 |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | SANDHILL SCIENTIFIC, INC. 8955 SOUTH RIDGELINE BLVD., UNIT #500 Highlands Ranch, CO 80126 |
| Contact | Linda Diederich |
| Correspondent | Linda Diederich SANDHILL SCIENTIFIC, INC. 8955 SOUTH RIDGELINE BLVD., UNIT #500 Highlands Ranch, CO 80126 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-18 |
| Decision Date | 1996-06-06 |