LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR— 510(k) K864858

Name: FDA 510(k) clearance K864858
Creator: U.S. Food and Drug Administration
Published: 1987-03-10

Substantially Equivalent

Biomedical Concepts, Inc.

FDA 510(k) clearance K864858 for LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR, Substantially Equivalent on 1987-03-10. Applicant: Biomedical Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Biomedical Concepts, Inc.
Product code: Code BZT
Device class: Class 2
Regulation: 21 CFR 868.1920
Advisory panel: Anesthesiology
Date received: 1986-12-11
Decision date: 1987-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmsford, NY, US

Download summary PDF View on FDA.gov ↗

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