The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Modular Volumetric Infusion Pump Sys.
| Device ID | K843274 |
| 510k Number | K843274 |
| Device Name: | MODULAR VOLUMETRIC INFUSION PUMP SYS |
| 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 | 1984-08-20 |
| Decision Date | 1984-10-19 |