The following data is part of a premarket notification filed by Via Medical Corp. with the FDA for Via 1-01 Infusion Pump/blood Chemistry System.
| Device ID | K935778 |
| 510k Number | K935778 |
| Device Name: | VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | VIA MEDICAL CORP. 11425 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | Dan Mckay |
| Correspondent | Dan Mckay VIA MEDICAL CORP. 11425 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | CCE |
| Subsequent Product Code | CCC |
| Subsequent Product Code | LZF |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-03 |
| Decision Date | 1996-12-05 |