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Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092875

by Taidoc Technology Corporation

Identifiers

510(k) Number
K092875 FDA 510(k)
FDA Product Code
NBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter is a dual-function diagnostic device classified as a System, Test, Blood Glucose, Over The Counter under FDA nomenclature. It measures blood glucose levels in fresh capillary whole blood and blood pressure, enabling simultaneous assessment of these vital metrics for monitoring metabolic and cardiovascular health.

This device is intended for use in both home and clinical settings. It is a single-use or reusable device (as specified in its design), with no explicit MRI safety restrictions noted in the data. The meter operates using standard blood glucose and blood pressure measurement protocols, requiring no special storage conditions beyond those recommended for medical devices. Its regulatory clearance under FDA 510(k) (K092875) confirms compliance with U.S. standards for over-the-counter diagnostic devices.

Frequently asked questions

What is the Echo TD-3227 Dual Blood Pressure/Glucose Meter used for?

The Echo TD-3227 is designed to simultaneously measure blood glucose levels in fresh capillary whole blood and blood pressure. This dual-function capability supports monitoring of both metabolic (glucose) and cardiovascular (blood pressure) health, making it suitable for patients managing conditions like diabetes or hypertension in home or clinical settings.

Is the Echo TD-3227 intended for single-use or reusable applications?

The Echo TD-3227 can be used either as a single-use or reusable device, depending on the specific configuration or design parameters set by the manufacturer. This flexibility allows users to choose based on their clinical or home-use needs, though proper cleaning and maintenance are required if reused to ensure accuracy and hygiene.

What regulatory clearance does the Echo TD-3227 hold in the U.S.?

The Echo TD-3227 holds FDA 510(k) clearance under the classification of a System, Test, Blood Glucose, Over The Counter. This clearance (K092875) confirms its compliance with U.S. standards for over-the-counter diagnostic devices, ensuring it meets regulatory requirements for safety and performance in measuring blood glucose and blood pressure.

Are there any special storage requirements for the Echo TD-3227?

The Echo TD-3227 does not require special storage conditions beyond those standard for medical devices. It should be stored in a clean, dry environment, protected from extreme temperatures, moisture, and direct sunlight to maintain its functionality and accuracy. Always follow manufacturer guidelines for optimal storage.

Does the Echo TD-3227 have any restrictions for use in MRI environments?

The available data does not explicitly mention MRI safety restrictions for the Echo TD-3227. If used in or near MRI environments, it is critical to verify compatibility with the specific MRI system and follow all safety protocols to avoid interference or damage to the device or the MRI machine.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Echo Td-3227 Dual Blood Pressure/Blood Glucose Meter, ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER… - FDA.report, PDF AUG 1 32010 Section 10. 510(k) Summary Submitter's Identification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taidoc Technology Corporation

Sources (1)

  • FDA 510(k) K092875 24 fields · synced Oct 1, 2026