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Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061073

by Taidoc Technology Corporation

Identifiers

510(k) Number
K061073 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Clever Check TD-3250 is a blood glucose and blood pressure measurement system designed for monitoring these vital health parameters. This device provides readings for both blood glucose levels and blood pressure, allowing for comprehensive health tracking in a single unit.

The Clever Check TD-3250 is supplied by Taidoc Technology Corporation and has received FDA 510(k) clearance with decision code SESE. The device is intended for use in settings where blood glucose and blood pressure monitoring is required, though specific sterility and single-use or reusable status information is not provided in the data.

Frequently asked questions

What is the Clever Check TD-3250 device used for?

The Clever Check TD-3250 is a measurement system designed for monitoring both blood glucose levels and blood pressure, allowing for comprehensive health tracking in a single unit for settings where these vital parameters need to be monitored.

What is the regulatory status of the Clever Check TD-3250?

The Clever Check TD-3250 has received FDA 510(k) clearance with decision code SESE, indicating it has been determined to be substantially equivalent to predicate devices for its intended use.

Is the Clever Check TD-3250 a single-use or reusable device?

The device data does not specify whether the Clever Check TD-3250 is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer or product documentation.

What are the model specifications of the Clever Check TD-3250?

The Clever Check TD-3250 is identified by model number TD-3250 and is manufactured by Taidoc Technology Corporation. It combines blood glucose and blood pressure measurement capabilities into one system, though specific technical measurements beyond this are not provided in the data.

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: Van Konfigurator - Clever Vans - Modelljahr 2027 - Büsgen …

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) K061073 24 fields · synced Oct 6, 2026