The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for The Simplicity Pump #2100 Infusion Pump.
| Device ID | K801546 |
| 510k Number | K801546 |
| Device Name: | THE SIMPLICITY PUMP #2100 INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | CRITIKON COMPANY,LLC 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 | 1980-07-07 |
| Decision Date | 1980-08-27 |