The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for The Amp 80/2 Pediatric Cycler System.
| Device ID | K811986 |
| 510k Number | K811986 |
| Device Name: | THE AMP 80/2 PEDIATRIC CYCLER SYSTEM |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-13 |
| Decision Date | 1981-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100627 | K811986 | 000 |