Cleared Traditional

ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE

K140134 · Starboard Medical, LLC · Anesthesiology
Jun 2014
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K140134 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE, a Stethoscope, Esophageal, With Electrical Conductors (Class II — Special Controls, product code BZT), submitted by Starboard Medical, LLC (Yorba Linda, US). The FDA issued a Cleared decision on June 16, 2014, 150 days after receiving the submission on January 17, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1920.

Submission Details

510(k) Number K140134 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2014
Decision Date June 16, 2014
Days to Decision 150 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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