510(k) K920438
- Device
- VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM
- Applicant
- VIA MEDICAL CORP.
- 510(k) number
- K920438
- Product code
- LZF
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1993-10-22
- Date received
- 1992-02-03
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Analytical Sampling
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAN MCKAY
- Address
- 10633 Roselle St. San Diego CA US 92121 92121
FDA Registration Numbers#
- 1625392
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192785 | OptiScanner® 5000 Glucose Monitoring System | Optiscan Biomedical Corporation | 2020-02-05 |
| K162042 | OptiScanner 5000 Glucose Monitoring System | Optiscan Biomedical Corp. | 2017-10-16 |
| K011238 | RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM | Metracor Technologies, Inc. | 2002-01-08 |
| K951739 | PUMP/BLOOD CHEMISTRY MONITOR | Via Medical Corp. | 1996-02-28 |
| K922997 | VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. | Via Medical Corp. | 1994-01-11 |
| K882830 | INFUSION PUMP | Pemlab Corp. | 1988-12-30 |
Legacy Summary#
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FDA Review#
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