The following data is part of a premarket notification filed by Cryosan, Inc. with the FDA for Infusion Pump.
| Device ID | K831953 |
| 510k Number | K831953 |
| Device Name: | INFUSION PUMP |
| Classification | Pump, Blood, Extra-luminal |
| Applicant | CRYOSAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-15 |
| Decision Date | 1983-07-19 |