CORE 500 Digital Stethoscope

Q: What is the product code of K233609?

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

FDA 510(k) K233609 · Eko Health, Inc.

Substantially Equivalent

510(k) numberK233609

Submission

Device name: CORE 500 Digital Stethoscope
Applicant: Eko Health, Inc.
Emeryville, CA, US
Received: November 13, 2023
Decision date: March 28, 2024
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

510(k)	Device	Applicant	Decision
K261494	Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional	Shanghai Hulu Devices Co., Ltd.	07/31/2026SE
K261694	CORE 300 Digital StethoscopeDQD · Traditional	Eko Health, Inc.	07/23/2026SE
K252915	AiSteth®DQD · Traditional	Ai Health Highway India Pvt., Ltd.	05/22/2026SE
K252089	Tyto Stethoscope (G3)DQD · Traditional	Tyto Care , Ltd.	03/12/2026SE
K252076	Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional	Kneevoice, Inc.	02/06/2026SE
K252284	eMurmur Heart AIDQD · Traditional	Csd Labs	12/19/2025SE
K252595	Stethophone ProDQD · Special	Sparrow Acoustics, Inc.	09/12/2025SE
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
K261694	CORE 300 Digital StethoscopeDQD · Traditional	07/23/2026SE
K251494	Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional	08/12/2025SE
K233409	Eko Low Ejection Fraction Tool (ELEFT)QYE · Traditional	03/28/2024SE

Questions and answers

When was CORE 500 Digital Stethoscope cleared by the FDA?

CORE 500 Digital Stethoscope (K233609) received a 510(k) decision of Substantially Equivalent on March 28, 2024, 136 days after the submission was received.

What is the product code of K233609?

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