The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Accupro Volumetric Infusion Pump W/rs232.
Device ID | K841922 |
510k Number | K841922 |
Device Name: | ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 |
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 | 1984-05-10 |
Decision Date | 1984-07-13 |