The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model Iv6000 Infusion Pump.
Device ID | K790332 |
510k Number | K790332 |
Device Name: | MODEL IV6000 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 | 1979-02-16 |
Decision Date | 1979-04-10 |