The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Infusion Equipment, Intravenous.
Device ID | K760370 |
510k Number | K760370 |
Device Name: | INFUSION EQUIPMENT, INTRAVENOUS |
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 | 1976-08-05 |
Decision Date | 1976-08-23 |