The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Analgraph.
| Device ID | K941801 |
| 510k Number | K941801 |
| Device Name: | ANALGRAPH |
| Classification | Monitor, Esophageal Motility, And Tube |
| 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 | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-12 |
| Decision Date | 1995-09-08 |