The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Amp Direct Vascular Monitoring System.
| Device ID | K792646 |
| 510k Number | K792646 |
| Device Name: | AMP DIRECT VASCULAR MONITORING SYSTEM |
| Classification | Ring, Annuloplasty |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-21 |
| Decision Date | 1980-02-11 |