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Hommed Sentry IIIB-F Patient Monitor System

by Hommed, LLC

510(k) K040651

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 NumberK040651 Date10 Aug 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  • Withdrawn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, 21 Sep 2026

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

The Hommed Sentry IIIB-F Patient Monitor System is a device designed for measuring and displaying patient physiological functions including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. It is intended for use in home and healthcare facility applications under physician orders to allow retrospective review of certain patient vital signs.

The system is available with physicians' orders only and can be used by patients in home settings or by healthcare providers in clinical environments. The device is supplied as a complete system and is authorized under FDA 510(k) K040651 with product code DXN. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the data.

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Questions

AI-generated answers, 21 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 Hommed Sentry IIIB-F Patient Monitor System used for?

    The Hommed Sentry IIIB-F Patient Monitor System is designed for measuring and displaying patient physiological functions including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. It is intended for use in home and healthcare facility applications under physician orders to allow retrospective review of certain patient vital signs.

  • How is the Hommed Sentry IIIB-F Patient Monitor System supplied?

    The device is supplied as a complete system and is available with physicians' orders only. It can be used by patients in home settings or by healthcare providers in clinical environments. The system is authorized under FDA 510(k) K040651 with product code DXN.

  • Is the Hommed Sentry IIIB-F Patient Monitor System sterile or single-use?

    No information regarding sterility, single-use or reusable status is provided in the device data. The product is supplied as a complete system, but specific details about sterility or whether it's designed for single-use or multiple uses are not included in the available information.

  • What are the regulatory approvals for the Hommed Sentry IIIB-F Patient Monitor System?

    The Hommed Sentry IIIB-F Patient Monitor System is authorized under FDA 510(k) K040651 with product code DXN. It received a traditional clearance with a decision code of SESE (Substantially Equivalent) on 2004-08-10, and was reviewed by the Cardiovascular advisory committee.