Drg Conventional Electronic Digital Stethoscope, Model Echop 200-00
by Doctor'S Research Group, Inc. 510(k)
Active
510(k) K991714
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991714 | Date10 Dec 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
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.
Other devices from Doctor'S Research Group, Inc.
Questions
AI-generated answers, 6 Oct 2026
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.