ESOPHAGEAL STETHESCOPE— 510(k) K800463

Name: FDA 510(k) clearance K800463
Creator: U.S. Food and Drug Administration
Published: 1980-03-10

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K800463 for ESOPHAGEAL STETHESCOPE, Substantially Equivalent on 1980-03-10. Applicant: Medical Components, Inc.. Device class: 1.

Clearance details

Applicant: Medical Components, Inc.
Product code: Code BZW
Device class: Class 1
Regulation: 21 CFR 868.1910
Advisory panel: Anesthesiology
Date received: 1980-02-29
Decision date: 1980-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K843070 — ESOPHAGEAL STETHOSCOPES1984-08-24
K841574 — QUAZAR ESOPHAGEAL STETHOSCOPE1984-08-15

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