The following data is part of a premarket notification filed by Y with the FDA for Model 460 Intermittent Medication Deliv.
Device ID | K823018 |
510k Number | K823018 |
Device Name: | MODEL 460 INTERMITTENT MEDICATION DELIV |
Classification | Monitor, Electric For Gravity Flow Infusion Systems |
Applicant | Y 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 | 1982-10-13 |
Decision Date | 1983-01-26 |