The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Volumetric Infusion Pump.
| Device ID | K812021 |
| 510k Number | K812021 |
| Device Name: | VOLUMETRIC INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-20 |
| Decision Date | 1981-07-31 |