K831953 is an FDA 510(k) clearance for the INFUSION PUMP. This device is classified as a Pump, Blood, Extra-luminal (Class II - Special Controls, product code FIR).
Submitted by Cryosan, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 34 days after receiving the submission on June 15, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K831953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1983 |
| Decision Date | July 19, 1983 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FIR — Pump, Blood, Extra-luminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |