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VoqX Electronic Stethoscope

by Sanolla, Ltd.

510(k) K212709

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 NumberK212709 Date15 Mar 2022ClearedStatusActive

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  • Withdrawn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
FDA applicant
Sanolla , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 VoqX Electronic Stethoscope is a device for auscultation, designed to capture and analyze heart and lung sounds. It is an electronic stethoscope that provides full-spectrum sound detection capabilities.

The device is manufactured by Sanolla, Ltd. and is FDA 510(k) cleared with product code DQD. It is intended for use in cardiovascular applications and is supplied in various models as indicated by the manufacturer.

Questions

AI-generated answers, 19 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 VoqX Electronic Stethoscope used for?

    The VoqX Electronic Stethoscope is designed for auscultation, specifically to capture and analyze heart and lung sounds. It is intended for use in cardiovascular applications, providing full-spectrum sound detection capabilities.

  • How is the VoqX Electronic Stethoscope supplied?

    The device is manufactured by Sanolla, Ltd. and is supplied in various models as indicated by the manufacturer. The specific models and their configurations are detailed by the manufacturer.

  • What is the regulatory status of the VoqX Electronic Stethoscope?

    The VoqX Electronic Stethoscope is FDA 510(k) cleared with product code DQD. It has been determined to be substantially equivalent to predicate devices for cardiovascular applications.

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

    The device data does not specify whether the VoqX Electronic Stethoscope is reusable or single-use. This information should be obtained directly from the manufacturer or product documentation.

  • What are the storage requirements for the VoqX Electronic Stethoscope?

    The device data does not include specific storage requirements for the VoqX Electronic Stethoscope. Storage instructions should be referenced from the manufacturer's product manual or packaging.