MyGlucoHealth Wireless System
K-Number: K143169 · 2016-01-08
ApplicantEntra Health Systems
Decision Date2016-01-08
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
MyGlucoHealth Wireless System is a medical device manufactured by Entra Health Systems. It received FDA 510(k) clearance on 2016-01-08 under approval number K143169. 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 MyGlucoHealth Wireless System?
MyGlucoHealth Wireless System is a medical device that received FDA 510(k) clearance on 2016-01-08. It is manufactured by Entra Health Systems. The 510(k) number is K143169.
When was MyGlucoHealth Wireless System approved by the FDA?
MyGlucoHealth Wireless System received FDA 510(k) clearance on 2016-01-08, under approval number K143169.
What company makes MyGlucoHealth Wireless System?
MyGlucoHealth Wireless System is manufactured by Entra Health Systems.
What is the FDA product code for MyGlucoHealth Wireless System?
The FDA product code for MyGlucoHealth Wireless 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.