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Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care …

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152363

by Philips Medical Systems

Identifiers

510(k) Number
K152363 FDA 510(k)
FDA Product Code
DXQ 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 Value Care Cuffs are blood pressure measurement cuffs designed for non-invasive blood pressure (NIBP) monitoring in adults, children, and infants. These cuffs are part of a non-invasive blood pressure monitoring system, providing accurate cuff-based measurements for clinical assessment of blood pressure in various patient populations.

These cuffs are supplied as single-use or reusable components, depending on the model, and are intended for use in clinical settings such as hospitals, medical offices, and home care environments. They are regulated under FDA 510(k) clearance (K152363) and comply with the Medical Device Regulation (MDR). The Efficia Adult NIBP Airhose variants (1.5 M and 3 M) are designed for compatibility with Philips Medical Systems’ non-invasive blood pressure monitoring devices.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems

Sources (2)

  • FDA 510(k) K152363 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026