Lifesound Esophageal Stethoscope

FDA 510(k) K062020 · Novamed, LLC

Substantially Equivalent

510(k) numberK062020

Submission

Device name
Lifesound Esophageal Stethoscope
Applicant
Novamed, LLC
Bonita Springs, FL, US
Received
July 17, 2006
Decision date
September 5, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZT – Stethoscope, Esophageal, With Electrical Conductors
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1920
Specialty
Anesthesiology

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K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional Deroyal Industries, Inc.04/02/2020SE
K140134Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope…BZT · Traditional Starboard Medical, LLC06/16/2014SE
K111050Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with…BZT · Traditional Starboard Medical, LLC04/12/2012SE
K092716Esophageal StethoscopeBZT · Traditional Truer Medical, Inc.09/17/2009SE
K072621Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorBZT · Traditional Cincinnati Sub-Zero Products, Inc.12/13/2007SE
K982193Esophageal StethoscopeBZT · Traditional Shore Medical, Inc.09/01/1998SE
K973839Disposable Esophageal StethoscopeBZT · Traditional Catheter Research, Inc.03/19/1998SE
K961060Aristo Esophageal StethoscopeBZT · Traditional Aristo Medical Products, Inc.06/19/1996SE
K953793IntroscopeBZT · Traditional Polamedco, Inc.11/29/1995SE

More from Polamedco, Inc.

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K063477Novamed MRI Conditional Laryngoscope SetCCW · Traditional 02/09/2007SE
K000718ChromostreakJSN · Traditional 08/24/2000SE
K974428DipstreakJSI · Traditional 07/30/1998SE

Questions and answers

When was Lifesound Esophageal Stethoscope cleared by the FDA?

Lifesound Esophageal Stethoscope (K062020) received a 510(k) decision of Substantially Equivalent on September 5, 2006, 50 days after the submission was received.

What is the product code of K062020?

The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.