The following data is part of a premarket notification filed by Optiscan Biomedical Corp. with the FDA for Optiscanner 5000 Glucose Monitoring System.
| Device ID | K162042 |
| 510k Number | K162042 |
| Device Name: | OptiScanner 5000 Glucose Monitoring System |
| Classification | Pump, Infusion, Analytical Sampling |
| Applicant | OPTISCAN BIOMEDICAL CORP. 24590 CLAWITER ROAD Hayward, CA 94545 |
| Contact | Don Webber |
| Correspondent | Don Webber OPTISCAN BIOMEDICAL CORP. 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 | 2016-07-25 |
| Decision Date | 2017-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003892504 | K162042 | 000 |
| 00850003892054 | K162042 | 000 |