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Sphygomano Meter

by Fraser Harlake, Inc. 510(k)

Active United States

510(k) K833799

Overview

The Sphygomano Meter is a medical device used for measuring blood pressure. It is classified under the DXN product code and falls under the cardiovascular medical specialty.

This device is supplied by Fraser Harlake, Inc. and received FDA 510(k) clearance on May 14, 1984, with the K number K833799. It is a traditional clearance device that was determined to be substantially equivalent. No information regarding sterility, single-use or reusable status, MRI safety, or sizes is provided in the data.

AI-generated from registry data, 26 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 NumberK833799 Date14 May 1984ClearedStatusActive

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
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Sphygomano Meter used for?

    The Sphygomano Meter is a medical device specifically designed for measuring blood pressure. It falls under the cardiovascular medical specialty and is classified under the DXN product code.

  • What is the regulatory status of the Sphygomano Meter?

    The Sphygomano Meter received FDA 510(k) clearance on May 14, 1984, with K number K833799. It was determined to be substantially equivalent through a traditional clearance process.

  • Is the Sphygomano Meter sterile and is it single-use or reusable?

    The device data does not provide information regarding sterility, single-use status, or whether the device is reusable. This information would need to be obtained directly from the manufacturer.

  • What sizes and models of the Sphygomano Meter are available?

    The device data does not specify available sizes or models for the Sphygomano Meter. For detailed information about available configurations, it would be necessary to contact the manufacturer directly.