OptiScanner® 5000 Glucose Monitoring System
Pump, Infusion, Analytical Sampling
Optiscan Biomedical Corporation
The following data is part of a premarket notification filed by Optiscan Biomedical Corporation with the FDA for Optiscanner® 5000 Glucose Monitoring System.
Pre-market Notification Details
| Device ID | K192785 |
| 510k Number | K192785 |
| Device Name: | OptiScanner® 5000 Glucose Monitoring System |
| Classification | Pump, Infusion, Analytical Sampling |
| Applicant | Optiscan Biomedical Corporation 24590 Clawiter Road Hayward, CA 94545 |
| Contact | Charles Zimliki |
| Correspondent | Charles Zimliki Optiscan Biomedical Corporation 24590 Clawiter Road Hayward, CA 94545 |
| Product Code | LZF |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-02-05 |
Trademark Results [OptiScanner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTISCANNER 78627081 not registered Dead/Abandoned |
OptiScan Biomedical Corporation 2005-05-10 |
 OPTISCANNER 77738076 3786059 Live/Registered |
OptiScan Biomedical Corporation 2009-05-15 |
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