K920438 is an FDA 510(k) clearance for the VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM. This device is classified as a Pump, Infusion, Analytical Sampling (Class II - Special Controls, product code LZF).
Submitted by Via Medical Corp. (San Diego, US). The FDA issued a Cleared decision on October 22, 1993, 627 days after receiving the submission on February 3, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K920438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | February 03, 1992 |
| Decision Date | October 22, 1993 |
| Days to Decision | 627 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZF — Pump, Infusion, Analytical Sampling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |