The following data is part of a premarket notification filed by Imed Corp. with the FDA for Imed Drop Rate Calculator #340.
| Device ID | K801734 |
| 510k Number | K801734 |
| Device Name: | IMED DROP RATE CALCULATOR #340 |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | IMED CORP. 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 | 1980-07-25 |
| Decision Date | 1980-10-23 |