The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Simplicity Infusion Pump Model 2100a.
| Device ID | K803078 |
| 510k Number | K803078 |
| Device Name: | SIMPLICITY INFUSION PUMP MODEL 2100A |
| 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 | 1980-12-05 |
| Decision Date | 1981-01-28 |