Electronic Stethoscope DS301

Q: What is the product code of K160023?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.

FDA 510(k) K160023 · Imediplus, Inc.

Substantially Equivalent

510(k) numberK160023

Submission

Device name: Electronic Stethoscope DS301
Applicant: Imediplus, Inc.
Chubei City, TW
Received: January 6, 2016
Decision date: September 30, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DQD – Stethoscope, Electronic
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1875
Specialty: Cardiovascular

Other 510(k)s with product code DQD

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K252284	eMurmur Heart AIDQD · Traditional	Csd Labs	12/19/2025SE
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K251494	Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional	Eko Health, Inc.	08/12/2025SE
K242971	AccurSound Electronic Stethoscope (AS101)DQD · Traditional	Heroic Faith International , Ltd.	11/25/2024SE
K240901	StethophoneDQD · Traditional	Sparrow Acoustics, Inc.	09/19/2024SE

More from Sparrow Acoustics, Inc.

510(k)	Device	Decision
K182196	Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model…DQD · Traditional	09/11/2018SE
K173663	Electronic Stethoscope DS3011ADQD · Abbreviated	08/17/2018SE

Questions and answers

When was Electronic Stethoscope DS301 cleared by the FDA?

Electronic Stethoscope DS301 (K160023) received a 510(k) decision of Substantially Equivalent on September 30, 2016, 268 days after the submission was received.

What is the product code of K160023?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.