The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Amp Mark Iv Infusion Pump.
| Device ID | K811918 |
| 510k Number | K811918 |
| Device Name: | AMP MARK IV INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-02 |
| Decision Date | 1981-07-20 |