Via 1-01 Infusion Pump Blood Chemistry System
FDA 510(k) K920438 · Via Medical Corp.
510(k) numberK920438
Submission
- Device name
- Via 1-01 Infusion Pump Blood Chemistry System
- Applicant
- Via Medical Corp.
San Diego, CA, US - Received
- February 3, 1992
- Decision date
- October 22, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K192785 | OptiScanner® 5000 Glucose Monitoring SystemLZF · Traditional | Optiscan Biomedical Corporation | 02/05/2020SE |
| K162042 | OptiScanner 5000 Glucose Monitoring SystemLZF · Traditional | Optiscan Biomedical Corp. | 10/16/2017SE |
| K011238 | Roda (Real Time Oxygen Dynamics Analysis) Monitoring SystemLZF · Traditional | Metracor Technologies, Inc. | 01/08/2002SE |
| K951739 | Pump/Blood Chemistry MonitorLZF · Traditional | Via Medical Corp. | 02/28/1996SE |
| K922997 | Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.LZF · Traditional | Via Medical Corp. | 01/11/1994SEKD |
| K882830 | Infusion PumpLZF · Traditional | Pemlab Corp. | 12/30/1988SE |
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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 (K920438) received a 510(k) decision of Unknown on October 22, 1993, 627 days after the submission was received.
What is the product code of K920438?
The FDA product code is LZF – Pump, Infusion, Analytical Sampling, a Class II (moderate risk) device regulated under 21 CFR 880.5725.