The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Infutrol 7000 Infusion Pump.
Device ID | K832008 |
510k Number | K832008 |
Device Name: | INFUTROL 7000 INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | VALLEYLAB, INC. 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 | 1983-06-23 |
Decision Date | 1983-08-12 |