510(k) K162042
- Device
- OptiScanner 5000 Glucose Monitoring System
- Applicant
- OPTISCAN BIOMEDICAL CORP.
- 510(k) number
- K162042
- Product code
- LZF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-16
- Date received
- 2016-07-25
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Analytical Sampling
- Medical specialty
- General Hospital
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DON WEBBER
- Address
- 24590 Clawiter Rd. Hayward CA US 94545 94545
FDA Registration Numbers#
- 1625392
- 1649518
Source Documents#
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 |
| 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 |
| K920438 | VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM | Via Medical Corp. | 1993-10-22 |
| K882830 | INFUSION PUMP | Pemlab Corp. | 1988-12-30 |
Legacy Summary#
summary
FDA Review#
Decision Summary