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 | K920438 |
510k Number | K920438 |
Device Name: | VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM |
Classification | Pump, Infusion, Analytical Sampling |
Applicant | VIA MEDICAL CORP. 10633 ROSELLE ST. San Diego, CA 92121 |
Contact | Dan Mckay |
Correspondent | Dan Mckay VIA MEDICAL CORP. 10633 ROSELLE ST. San Diego, CA 92121 |
Product Code | LZF |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-03 |
Decision Date | 1993-10-22 |