The following data is part of a premarket notification filed by Centaur Sciences, Inc. with the FDA for Guardian Ii I.v. Controller.
Device ID | K790836 |
510k Number | K790836 |
Device Name: | GUARDIAN II I.V. CONTROLLER |
Classification | Monitor, Electric For Gravity Flow Infusion Systems |
Applicant | CENTAUR SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLN |
CFR Regulation Number | 880.2420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-30 |
Decision Date | 1979-07-30 |