K935778 is an FDA 510(k) clearance for the VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM. This device is classified as a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II - Special Controls, product code CCE).
Submitted by Via Medical Corp. (San Diego, US). The FDA issued a Cleared decision on December 5, 1996, 1098 days after receiving the submission on December 3, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1200.
| 510(k) Number | K935778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | December 03, 1993 |
| Decision Date | December 05, 1996 |
| Days to Decision | 1098 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1200 |