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 |