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YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260747

by Nihon Kohden Corporation

Identifiers

510(k) Number
K260747 FDA 510(k)
FDA Product Code
DXQ FDA 510(k)
Models / Variants
YP-710T Series NIBP Cuff FDA 510(k)
YP-840T Series Disposable Cuff FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1120 FDA 510(k)
Regulation Number
870.1120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The YP-710T Series NIBP Cuff and YP-840T Series Disposable Cuff are non-invasive blood pressure measurement devices designed for accurate and reliable blood pressure monitoring. These cuffs are part of a series of medical devices intended for use in clinical settings to assess blood pressure levels in patients. The YP-840T is a disposable variant, while the YP-710T is part of a reusable series.

The YP-710T Series NIBP Cuff is reusable and supplied in a sterile condition, while the YP-840T Series Disposable Cuff is intended for single-use applications. Both devices are compatible with MRI-safe environments and are available in various sizes to accommodate different patient anatomies. Storage should be performed in a dry, cool place away from direct sunlight. The devices are regulated under FDA 510(k) clearance, with a decision of Substantially Equivalent.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden Corporation

Sources (1)

  • FDA 510(k) K260747 24 fields · synced Oct 6, 2026