Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.

FDA 510(k) K922997 · Via Medical Corp.

Unknown

510(k) numberK922997

Submission

Device name
Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.
Applicant
Via Medical Corp.
San Diego, CA, US
Received
June 22, 1992
Decision date
January 11, 1994
Decision
Unknown (SEKD)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LZF – Pump, Infusion, Analytical Sampling
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

Other 510(k)s with product code LZF

510(k)DeviceApplicantDecision
K192785OptiScanner® 5000 Glucose Monitoring SystemLZF · Traditional Optiscan Biomedical Corporation02/05/2020SE
K162042OptiScanner 5000 Glucose Monitoring SystemLZF · Traditional Optiscan Biomedical Corp.10/16/2017SE
K011238Roda (Real Time Oxygen Dynamics Analysis) Monitoring SystemLZF · Traditional Metracor Technologies, Inc.01/08/2002SE
K951739Pump/Blood Chemistry MonitorLZF · Traditional Via Medical Corp.02/28/1996SE
K920438Via 1-01 Infusion Pump Blood Chemistry SystemLZF · Traditional Via Medical Corp.10/22/1993SEKD
K882830Infusion PumpLZF · Traditional Pemlab Corp.12/30/1988SE

More from Pemlab Corp.

510(k)DeviceDecision
K935778Via 1-01 Infusion Pump/Blood Chemistry SystemCCE · Traditional 12/05/1996SEKD
K951739Pump/Blood Chemistry MonitorLZF · Traditional 02/28/1996SE
K920438Via 1-01 Infusion Pump Blood Chemistry SystemLZF · Traditional 10/22/1993SEKD

Questions and answers

When was Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod. cleared by the FDA?

Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod. (K922997) received a 510(k) decision of Unknown on January 11, 1994, 568 days after the submission was received.

What is the product code of K922997?

The FDA product code is LZF – Pump, Infusion, Analytical Sampling, a Class II (moderate risk) device regulated under 21 CFR 880.5725.