The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Amp 80/2 Outflow Monitor Modification.
| Device ID | K823827 |
| 510k Number | K823827 |
| Device Name: | AMP 80/2 OUTFLOW MONITOR MODIFICATION |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-20 |
| Decision Date | 1983-03-17 |