Cleared Traditional

ESOPHAGEAL STETHOSCOPE

K092716 · Truer Medical, Inc. · Anesthesiology
Sep 2009
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K092716 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE, a Stethoscope, Esophageal, With Electrical Conductors (Class II — Special Controls, product code BZT), submitted by Truer Medical, Inc. (Orange, US). The FDA issued a Cleared decision on September 17, 2009, 14 days after receiving the submission on September 3, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1920.

Submission Details

510(k) Number K092716 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2009
Decision Date September 17, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

Similar Devices — BZT Stethoscope, Esophageal, With Electrical Conductors

All 45
Mon-a-Therm? Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
K251025 · Covidien, LLC · Dec 2025
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K193027 · Deroyal Industries, Inc. · Apr 2020
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
K140134 · Starboard Medical, LLC · Jun 2014
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
K111050 · Starboard Medical, LLC · Apr 2012
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
K072621 · Cincinnati Sub-Zero Products, Inc. · Dec 2007
LIFESOUND ESOPHAGEAL STETHOSCOPE
K062020 · Novamed, LLC · Sep 2006