FDA 510(k)

TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System

K-Number: K231476 · 2023-12-01

Decision Date2023-12-01

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System is a medical device manufactured by Sinocare, Inc.. It received FDA 510(k) clearance on 2023-12-01 under approval number K231476. 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 TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System?

TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Sinocare, Inc.. The 510(k) number is K231476.

When was TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System approved by the FDA?

TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System received FDA 510(k) clearance on 2023-12-01, under approval number K231476.

What company makes TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System?

TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System is manufactured by Sinocare, Inc..

What is the FDA product code for TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System?

The FDA product code for TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.