The following data is part of a premarket notification filed by Via Medical Corp. with the FDA for Pump/blood Chemistry Monitor.
Device ID | K951739 |
510k Number | K951739 |
Device Name: | PUMP/BLOOD CHEMISTRY MONITOR |
Classification | Pump, Infusion, Analytical Sampling |
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 | LZF |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-14 |
Decision Date | 1996-02-28 |