LIFESOUND - ELECTRONIC STETHOSCOPE— 510(k) K844804

Name: FDA 510(k) clearance K844804
Creator: U.S. Food and Drug Administration
Published: 1985-02-13

Substantially Equivalent

Biomedical Concepts, Inc.

FDA 510(k) clearance K844804 for LIFESOUND - ELECTRONIC STETHOSCOPE, Substantially Equivalent on 1985-02-13. Applicant: Biomedical Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Biomedical Concepts, Inc.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 1984-12-11
Decision date: 1985-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plans, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQD

view all

K261494 — Smart Wireless Stethoscope (4 models)2026-07-31
K261694 — CORE 300 Digital Stethoscope2026-07-23
K252915 — AiSteth®2026-05-22
K252089 — Tyto Stethoscope (G3)2026-03-12
K252076 — Kneevoice Cartilage Evaluation System (750-3600-001)2026-02-06

More clearances from Biomedical Concepts, Inc.

view all

K864858 — LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR1987-03-10
K811928 — LIFESOUND ESOPHAGEAL STETHOSCOPE1981-07-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.