The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Infusion Pump.
Device ID | K832470 |
510k Number | K832470 |
Device Name: | INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | DELTA MEDICAL INDUSTRIES 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 | 1983-07-26 |
Decision Date | 1984-02-28 |