The following data is part of a premarket notification filed by Sandhill with the FDA for Sandhill Ams.
| Device ID | K863312 |
| 510k Number | K863312 |
| Device Name: | SANDHILL AMS |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | SANDHILL 224 E. OLIVE AVE. Burbank, CA 91502 |
| Contact | Robert R Chambers |
| Correspondent | Robert R Chambers SANDHILL 224 E. OLIVE AVE. Burbank, CA 91502 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-26 |
| Decision Date | 1986-12-03 |