The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Secura Iv Volumetric Infusion Pump.
| Device ID | K830355 | 
| 510k Number | K830355 | 
| Device Name: | SECURA IV VOLUMETRIC INFUSION PUMP | 
| Classification | Pump, Infusion | 
| Applicant | DIATEK, INC. 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 | 1983-02-03 | 
| Decision Date | 1983-03-01 |