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Central Station, Version 3.3H

by Hommed, LLC

510(k) K040032

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 NumberK040032 Date27 Feb 2004ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

Central Station, Version 3.3H is a system for measurement of blood pressure, non-invasive, as classified under product code DXN and regulation 870.1130. It is designed to retrospectively receive, display, and store certain monitored physiological parameters received from adult and pediatric patients over 12 years of age, including NIBP, pulse rate, SpO2, temperature, and weight.

The device includes an HL7 interface to transfer data from the HomMed Central Station to vendor systems and storage media. It was cleared through the FDA 510(k) process under submission K040032, with a decision of substantially equivalent on February 27, 2004. The device is supplied by Hommed, LLC and is intended for use in cardiovascular monitoring settings.

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the Central Station, Version 3.3H used for?

    The Central Station, Version 3.3H is designed to retrospectively receive, display, and store monitored physiological parameters such as non-invasive blood pressure, pulse rate, SpO2, temperature, and weight from adult and pediatric patients over 12 years of age in cardiovascular monitoring settings.

  • How does the Central Station, Version 3.3H transfer data to other systems?

    The device includes an HL7 interface that enables the transfer of data from the HomMed Central Station to vendor systems and storage media, allowing integration with external healthcare information systems for data management and record keeping.

  • Is the Central Station, Version 3.3H intended for single-patient or multi-patient use?

    The Central Station, Version 3.3H is intended for use in clinical environments where it can receive data from multiple adult and pediatric patients over 12 years of age, making it suitable for multi-patient monitoring in cardiovascular care settings.