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Lifesound Electronic Stethoscope

by Biomedical Concepts, Inc.

510(k) K844804

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 NumberK844804 Date13 Feb 1985ClearedStatusActive

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  • Withdrawn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
DQD
Device Class
Class II
Regulation
21 CFR Part 870.1875
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 Lifesound Electronic Stethoscope is an electronic auscultation device designed for amplifying and processing body sounds, specifically heart and lung sounds. Classified under the FDA nomenclature as a Stethoscope, Electronic, it aids clinicians in diagnosing cardiovascular conditions by enhancing the clarity of auscultatory signals.

This device is intended for reusable clinical use and falls under FDA Class II regulation (21 CFR 870.1875) with a product code of DQD. It requires FDA 510(k) clearance and was granted Substantially Equivalent status under a traditional review pathway. Supplied in a sterile or non-sterile configuration depending on model, it is intended for use in hospital, clinic, or physician office settings.

Other devices from Biomedical Concepts, 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 is the Lifesound Electronic Stethoscope used for?

    The Lifesound Electronic Stethoscope is designed to amplify and process body sounds, particularly heart and lung sounds, to aid clinicians in diagnosing cardiovascular conditions. By enhancing auscultatory signals, it improves the clarity of sounds, making it easier to detect subtle abnormalities that may indicate heart or lung issues.

  • Is the Lifesound Electronic Stethoscope reusable or single-use?

    The Lifesound Electronic Stethoscope is intended for reusable clinical use. This design allows for repeated use in hospital, clinic, or physician office settings, provided proper cleaning and maintenance protocols are followed to ensure hygiene and functionality.

  • What configurations are available for the Lifesound Electronic Stethoscope?

    The Lifesound Electronic Stethoscope is supplied in either sterile or non-sterile configurations, depending on the specific model. The choice between sterile and non-sterile depends on the intended clinical use and infection control requirements of the facility.

  • What regulatory pathway was followed for the Lifesound Electronic Stethoscope?

    The Lifesound Electronic Stethoscope was granted FDA 510(k) clearance under a traditional review pathway and was determined to be Substantially Equivalent to a predicate device. It falls under FDA Class II regulation (21 CFR 870.1875) with a product code of DQD, ensuring it meets stringent safety and performance standards for electronic stethoscopes.

  • Where can the Lifesound Electronic Stethoscope be used?

    This device is intended for use in hospital, clinic, or physician office settings where cardiovascular auscultation is required. Its reusable design and amplification capabilities make it suitable for a variety of clinical environments where clear and accurate assessment of heart and lung sounds is essential.