Who else makes this device?

Name: Eko Core Digital Stethoscope
Brand: Eko Core Digital Stethoscope

Cardiovascular › DiagnosticStethoscope, Electronic

Eko Core Digital Stethoscope

The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization,…

Registry build 21.09.26

The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds.

3manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DQD
Manufacturer	City	Province	Registered as	Device types
Yahorng Dongguan Electronic Co Ltd	Guangdong	Guangdong	Contract manufacturer	8
ADC Ningbo Co., Ltd.	Ningbo	Zhejiang	Exporter	13
Suzhou Melodicare Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	3

Record

Regulatory record for Eko Core Digital Stethoscope
Listed by	Eko Devices, Inc., United States
FDA product code	DQD
Device type	Stethoscope, Electronic
Device class	Class 2
Regulation	21 CFR 870.1875
510(k)	K151319
Record published	2019-11-01
Record revised	2024-11-25 (version 7)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Over the counter	Yes
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Eko Core Digital Stethoscope
Catalogue number	Size	Status
E6		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
3M™ Littmann®	3M Company	29
Adscope®	American Diagnostic Corp.	14
Littmann®	3M Company	13
RNK Products	Rnk Products, Inc.	10
Tyto Stethoscope	Tyto Care, Ltd.	5
Steth IO	Steth IO	4
Heroic Faith	Heroic Faith International Ltd.	3
Stethophone Pro	Sparrow Acoustics Inc.	2
AeviceMD	Aevice Health Pte. Ltd.	2
Eko Core 500 and CAC500 Founder’s Edition bundle	Eko Devices, Inc.	1
Eko Core 500 and CAC500 Standard bundle	Eko Devices, Inc.	1
Stethophone	Sparrow Acoustics Inc.	1

Showing 12 of 79. All products under Stethoscope, Electronic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K230111	2023-05-26
K213794	2022-06-29
K200776	2020-04-06
K170874	2017-05-19
K151319	2015-08-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.