# K011898: E-Steth Electronic Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: E-Med Innovations, Inc.
- Decided: Sep 14, 2001 after 88 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Meditron Electronic Stethoscope: named in the summary without a submission number
- (no number) 3M Littman Electronic Stethoscope: named in the summary without a submission number

## Indications for use
The E-Steth Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart and other internal organs. Significant components include a control unit, installation software earphones, and a communication cable. The E-Steth amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode. The user must supply a personal computer with a Microsoft Windows 95/98 or NT 4.0 operating system, a sound card, and CD-ROM drive. The stored sounds can be transmitted via e-mail. This device is a stand-alone unit, has no software and operates using an analog system with a standard earpiece. It can be converted to electronic by the user buying and using a sound card. The E-Steth records the heartbeat as a stand-alone device. It can be connected to a computer to record information, but the software does not operate the stethoscope in any manner.

Source page: https://510kreport.com/device/K011898
Methodology: https://510kreport.com/methodology