Cleared Traditional

Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

K193027 · Deroyal Industries, Inc. · Anesthesiology
Apr 2020
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K193027 is an FDA 510(k) clearance for the Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French, a Stethoscope, Esophageal, With Electrical Conductors (Class II — Special Controls, product code BZT), submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 2, 2020, 155 days after receiving the submission on October 30, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1920.

Submission Details

510(k) Number K193027 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2019
Decision Date April 02, 2020
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZT — Stethoscope, Esophageal, With Electrical Conductors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1920

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