IWL2020 Blood Glucose Monitoring System
K-Number: K203711 · 2022-05-06
ApplicantRoche Diabetes Care, Inc.
Decision Date2022-05-06
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
IWL2020 Blood Glucose Monitoring System is a medical device manufactured by Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-05-06 under approval number K203711. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IWL2020 Blood Glucose Monitoring System?
IWL2020 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Roche Diabetes Care, Inc.. The 510(k) number is K203711.
When was IWL2020 Blood Glucose Monitoring System approved by the FDA?
IWL2020 Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-05-06, under approval number K203711.
What company makes IWL2020 Blood Glucose Monitoring System?
IWL2020 Blood Glucose Monitoring System is manufactured by Roche Diabetes Care, Inc..
What is the FDA product code for IWL2020 Blood Glucose Monitoring System?
The FDA product code for IWL2020 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.