Steth IO

Steth IO - The Smartphone Stethoscope for iPhone 7+ or 8+

Registry build 21.09.26
3manufacturers in China registered for this device type
4catalogue numbers in this listing

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 Steth IO
Listed by Steth IO
FDA product code DQD
Device type Stethoscope, Electronic
Device class Class 2
Regulation 21 CFR 870.1875
510(k) K160016
Record published 2018-04-09
Record revised 2024-11-25 (version 5)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Steth IO
Catalogue number Size Status
iPhone 7+/8+ In distribution
iPhone 7/8 In distribution
iPhone X In distribution
iPhone 6 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
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
Core 500 Digital Stethoscope – Bundle-ROG Eko Devices, Inc. 1

Showing 12 of 79. All products under Stethoscope, Electronic

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