Cleared Traditional

LIFESOUND ESOPHAGEAL STETHOSCOPE

K062020 · Novamed, LLC · Anesthesiology
Sep 2006
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K062020 is an FDA 510(k) clearance for the LIFESOUND ESOPHAGEAL STETHOSCOPE, a Stethoscope, Esophageal, With Electrical Conductors (Class II — Special Controls, product code BZT), submitted by Novamed, LLC (Bonita Springs, US). The FDA issued a Cleared decision on September 5, 2006, 50 days after receiving the submission on July 17, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1920.

Submission Details

510(k) Number K062020 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2006
Decision Date September 05, 2006
Days to Decision 50 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

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 STETHOSCOPE
K092716 · Truer Medical, Inc. · Sep 2009
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
K072621 · Cincinnati Sub-Zero Products, Inc. · Dec 2007