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Sphygmomanometer

by Eyvirco 510(k)

Active United States

510(k) K760157

Overview

A sphygmomanometer is a medical device used to measure blood pressure. It typically consists of an inflatable cuff, a measuring unit, and a mechanism for auscultation or oscillometric detection of blood flow.

The device is supplied as a reusable instrument and is not specified as MRI safe. It is authorized under FDA 510(k) clearance K760157 with product code DXQ, cleared on July 19, 1976, for cardiovascular use.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760157 Date19 Jul 1976ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Questions

  • What is a sphygmomanometer used for?

    A sphygmomanometer is a medical device used to measure blood pressure. It typically consists of an inflatable cuff, a measuring unit, and a mechanism for auscultation or oscillometric detection of blood flow.

  • Is the Eyvirco sphygmomanometer reusable or single-use?

    The Eyvirco sphygmomanometer is supplied as a reusable instrument. It is designed for multiple uses rather than being disposable, though it is not specified as MRI safe.

  • What regulatory approvals does this device have?

    The Eyvirco sphygmomanometer is authorized under FDA 510(k) clearance K760157 with product code DXQ, cleared on July 19, 1976, for cardiovascular use. It was determined to be substantially equivalent to other devices in this category.

  • How is the sphygmomanometer supplied?

    The device is supplied as a reusable instrument. The specific packaging or configuration details are not provided in the available information, but it includes the standard components of an inflatable cuff, measuring unit, and detection mechanism.