The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Home Pro Volumetric Infusion Pump.
| Device ID | K841374 |
| 510k Number | K841374 |
| Device Name: | HOME PRO VOLUMETRIC INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Daina Graham |
| Correspondent | Daina Graham AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1985-02-15 |