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FDA 510(k), K162042, OptiScanner 5000 Glucose Monitoring System
FDA 510(k), K162042, OptiScanner 5000 Glucose Monitoring System
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$149.00 USD
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510(K) Number: K162042
Device Name: OptiScanner 5000 Glucose Monitoring System
Manufacturer: OPTISCAN BIOMEDICAL CORP.
Device Classification Name: pump, infusion, analytical sampling
Regulation Number: 880.5725
Classification Product Code: LZF
Date Received: 07/25/2016
Decision Date: 10/16/2017
Regulation Medical Specialty: General Hospital
Device Name: OptiScanner 5000 Glucose Monitoring System
Manufacturer: OPTISCAN BIOMEDICAL CORP.
Device Classification Name: pump, infusion, analytical sampling
Regulation Number: 880.5725
Classification Product Code: LZF
Date Received: 07/25/2016
Decision Date: 10/16/2017
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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