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Drg Conventional Electronic Digital Stethoscope, Model Echop 200-00

by Doctor'S Research Group, Inc. 510(k)

Active United States

510(k) K991714

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991714 Date10 Dec 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 6 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 device is an electronic digital stethoscope, classified as a stethoscope, electronic under FDA regulations. It is designed to detect and transmit body sounds such as those from the heart, arteries, veins, and other internal organs.

It can be used as a standard stethoscope or in electronic digital mode, allowing the user to digitally record, amplify, or replay sounds at different speeds. The device is supplied non-sterile and is reusable, with FDA 510(k) clearance (K991714) as a Class II medical device.

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Questions

AI-generated answers, 6 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 DRG ECHOP 200-00 stethoscope used for?

    The DRG ECHOP 200-00 is designed to detect and transmit body sounds such as those from the heart, arteries, veins, and other internal organs, functioning as both a standard stethoscope and in electronic digital mode for recording, amplifying, or replaying sounds at different speeds.

  • Is the DRG ECHOP 200-00 stethoscope sterile or non-sterile, and is it single-use or reusable?

    The device is supplied non-sterile and is designed for reuse, meaning it can be cleaned and used multiple times after appropriate disinfection between patients.

  • What regulatory pathway was used for the DRG ECHOP 200-00 stethoscope?

    The DRG ECHOP 200-00 received FDA 510(k) clearance (K991714) as a Class II medical device, demonstrating substantial equivalence to a legally marketed predicate device.