Cleared Traditional

ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR

K111050 · Starboard Medical, LLC · Anesthesiology
Apr 2012
Decision
363d
Days
Class 2
Risk

About This 510(k) Submission

K111050 is an FDA 510(k) clearance for the ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR, 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 April 12, 2012, 363 days after receiving the submission on April 15, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1920.

Submission Details

510(k) Number K111050 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2011
Decision Date April 12, 2012
Days to Decision 363 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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