GlucoLeader Enhance Blood Glucose Monitoring System
K-Number: K182428 · 2019-05-08
ApplicantHmd Biomedical, Inc.
Decision Date2019-05-08
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
GlucoLeader Enhance Blood Glucose Monitoring System is a medical device manufactured by Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2019-05-08 under approval number K182428. 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 GlucoLeader Enhance Blood Glucose Monitoring System?
GlucoLeader Enhance Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-05-08. It is manufactured by Hmd Biomedical, Inc.. The 510(k) number is K182428.
When was GlucoLeader Enhance Blood Glucose Monitoring System approved by the FDA?
GlucoLeader Enhance Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-05-08, under approval number K182428.
What company makes GlucoLeader Enhance Blood Glucose Monitoring System?
GlucoLeader Enhance Blood Glucose Monitoring System is manufactured by Hmd Biomedical, Inc..
What is the FDA product code for GlucoLeader Enhance Blood Glucose Monitoring System?
The FDA product code for GlucoLeader Enhance 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.