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Mod. 587 Blood Pressure & Pulse Monitor

by Bio Mega Diagnostic, Inc.

510(k) K813556

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813556 Date22 Jan 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mod. 587 Blood Pressure and Pulse Monitor is a noninvasive blood pressure measurement system classified under FDA product code DXN. It measures systolic, diastolic, and mean arterial pressures via transducers, providing real-time pulse monitoring alongside blood pressure readings. Designed for clinical use, it falls under the cardiovascular specialty category and adheres to FDA guidelines for traditional 510(k) clearance.

This device is intended for single-use or reusable applications in clinical settings, though sterility and reuse specifications are not detailed in the provided data. It operates under FDA regulation 21 CFR 870.1130 and was granted FDA 510(k) clearance (K813556) in January 1982. No MRI safety information or specific storage requirements are noted in the available records.

Other devices from Bio Mega Diagnostic, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical measurements does the Mod. 587 Blood Pressure & Pulse Monitor provide?

    The Mod. 587 Blood Pressure & Pulse Monitor provides noninvasive measurements of systolic, diastolic, and mean arterial blood pressure. It also includes real-time pulse monitoring, making it suitable for assessing cardiovascular parameters in clinical settings.

  • Is the Mod. 587 Blood Pressure & Pulse Monitor intended for single-use or reusable applications?

    The device is designed for either single-use or reusable applications in clinical settings. However, specific sterility and reuse guidelines are not detailed in the provided data, so facility protocols should be followed to ensure proper use and maintenance.

  • What regulatory pathway was followed for FDA clearance of the Mod. 587?

    The Mod. 587 Blood Pressure & Pulse Monitor was granted FDA 510(k) clearance under Traditional review by the Cardiovascular (CV) Advisory Committee. It was classified under FDA product code DXN and determined to be substantially equivalent to a predicate device, with clearance granted on January 22, 1982.

  • Does the Mod. 587 Blood Pressure & Pulse Monitor have any special storage requirements?

    The available records do not specify any special storage requirements for the Mod. 587 Blood Pressure & Pulse Monitor. Standard clinical storage practices should be followed to maintain device integrity and functionality.

  • Is MRI safety information provided for the Mod. 587 Blood Pressure & Pulse Monitor?

    No MRI safety information is noted in the available records for the Mod. 587 Blood Pressure & Pulse Monitor. Users should consult manufacturer guidelines or facility protocols to ensure safe use in environments with MRI equipment.