Analyst, Model DSP 300

FDA 510(k) K950760 · Heart Sounds, Inc.

Substantially Equivalent

510(k) numberK950760

Submission

Device name
Analyst, Model DSP 300
Applicant
Heart Sounds, Inc.
M3b 1r15, CA
Received
February 17, 1995
Decision date
October 31, 1995
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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K261694CORE 300 Digital StethoscopeDQD · Traditional Eko Health, Inc.07/23/2026SE
K252915AiSteth®DQD · Traditional Ai Health Highway India Pvt., Ltd.05/22/2026SE
K252089Tyto Stethoscope (G3)DQD · Traditional Tyto Care , Ltd.03/12/2026SE
K252076Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional Kneevoice, Inc.02/06/2026SE
K252284eMurmur Heart AIDQD · Traditional Csd Labs12/19/2025SE
K252595Stethophone ProDQD · Special Sparrow Acoustics, Inc.09/12/2025SE
K251494Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional Eko Health, Inc.08/12/2025SE
K242971AccurSound Electronic Stethoscope (AS101)DQD · Traditional Heroic Faith International , Ltd.11/25/2024SE
K240901StethophoneDQD · Traditional Sparrow Acoustics, Inc.09/19/2024SE

Questions and answers

When was Analyst, Model DSP 300 cleared by the FDA?

Analyst, Model DSP 300 (K950760) received a 510(k) decision of Substantially Equivalent on October 31, 1995, 256 days after the submission was received.

What is the product code of K950760?

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