Core 500 Digital Stethoscope – Amethyst Earpiece

Core 500 Digital Stethoscope - Amethyst Earpiece: 1 catalogue number listed by Eko Devices, Inc., United States, under Stethoscope, Electronic. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26
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 Core 500 Digital Stethoscope – Amethyst Earpiece
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) K233609
Record published 2025-03-12

Specifications

Specifications
MRI safety MR Unsafe
Over the counter Yes
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Core 500 Digital Stethoscope – Amethyst Earpiece
Catalogue number Size Status
E8 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer