Via 1-01 Infusion Pump/Blood Chemistry System

Q: What is the product code of K935778?

The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.

FDA 510(k) K935778 · Via Medical Corp.

Unknown

510(k) numberK935778

Submission

Device name: Via 1-01 Infusion Pump/Blood Chemistry System
Applicant: Via Medical Corp.
San Diego, CA, US
Received: December 3, 1993
Decision date: December 5, 1996
Decision: Unknown (SEKD)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.1200
Specialty: Anesthesiology

Other 510(k)s with product code CCE

510(k)	Device	Applicant	Decision
K912145	System Athena-Product Enhancements, AnesthesiaCCE · Traditional	S & W Medico Teknik	05/05/1992SE
K910453	Tops Needle Tip Probe & PVC Tip ProbeCCE · Traditional	Baxter Healthcare Corp	08/13/1991SE
K905397	PB3200 Intra-Arterial Blood Gas Monitoring SystemCCE · Traditional	Puritan Bennett Corp.	05/14/1991SE
K896311	Optex Blood Gas Monitoring SystemCCE · Traditional	Optex Biomedical	01/03/1990SE
K890624	Tissue Oxygen Monitor System, Model IICCE · Traditional	Baxter Healthcare Corp	12/22/1989SE
K895150	Continucath 1000 Intravascular Oxygen MonitoringCCE · Traditional	Shiley, Inc.	11/28/1989SE
K895149	Neocath 1000 Umbilical Artery Oxygen Monitoring SyCCE · Traditional	Shiley, Inc.	11/28/1989SE
K884063	Bard Abg 100 Intravascular Oxygen Monitor SystemCCE · Traditional	C.R. Bard, Inc.	12/16/1988SE
K875225	Umbilical Artery Oxygen SensorCCE · Traditional	Ohmeda Medical	03/04/1988SE
K872896	Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional	American Bentley	02/12/1988SE

More from American Bentley

510(k)	Device	Decision
K951739	Pump/Blood Chemistry MonitorLZF · Traditional	02/28/1996SE
K922997	Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.LZF · Traditional	01/11/1994SEKD
K920438	Via 1-01 Infusion Pump Blood Chemistry SystemLZF · Traditional	10/22/1993SEKD

Questions and answers

When was Via 1-01 Infusion Pump/Blood Chemistry System cleared by the FDA?

Via 1-01 Infusion Pump/Blood Chemistry System (K935778) received a 510(k) decision of Unknown on December 5, 1996, 1,098 days after the submission was received.

What is the product code of K935778?

The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.