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E-Steth Electronic Stethoscope

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011898

by E-Med Innovations, Inc.

Identifiers

510(k) Number
K011898 FDA 510(k)
FDA Product Code
DQD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1875 FDA 510(k)
Regulation Number
870.1875 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An electronic stethoscope is a diagnostic aid used to amplify, record, store, play back, and transmit sounds associated with the heart and other internal organs. It consists of a control unit, installation software, earphones, and a communication cable.

The device is supplied as a reusable system intended for use in clinical settings for patient diagnosis, treatment, and monitoring. It has received FDA 510(k) clearance (K011898) and is classified as a Class II medical device under regulation number 870.1875 with product code DQD.

Frequently asked questions

What is the E-STETH Electronic Stethoscope used for?

The E-STETH Electronic Stethoscope is a diagnostic aid used to amplify, record, store, play back, and transmit sounds associated with the heart and other internal organs, supporting patient diagnosis, treatment, and monitoring in clinical environments.

Is the E-STETH Electronic Stethoscope reusable or single-use?

The device is supplied as a reusable system, meaning it is designed for repeated use in clinical settings after appropriate cleaning and maintenance between patients, not as a disposable single-use product.

What components are included with the E-STETH Electronic Stethoscope system?

The system consists of a control unit, installation software, earphones, and a communication cable, all working together to enable sound amplification, recording, storage, playback, and transmission for clinical use.

What regulatory clearance does the E-STETH Electronic Stethoscope have?

The device has received FDA 510(k) clearance under submission number K011898 and is classified as a Class II medical device under regulation 870.1875 with product code DQD.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: E-STETH ELECTRONIC STETHOSCOPE (K011898) — FDA 510 (k) - Innolitics, Electronic Stethoscope - vTitan, K011898 - Stethoscope, Electronic FDA 510 (k) APPLICATION FOR E-MED ..., Electronic Stethoscope - dvm360

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
E-Med Innovations, Inc.

Sources (1)

  • FDA 510(k) K011898 24 fields · synced Sep 21, 2026