The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Homepro Ii Volumetric Infusion Pump.
| Device ID | K870444 |
| 510k Number | K870444 |
| Device Name: | HOMEPRO II 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 | Nancy E Shadforth |
| Correspondent | Nancy E Shadforth 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 | 1987-02-03 |
| Decision Date | 1987-04-17 |