Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece

FDA 510(k) K140134 · Starboard Medical, LLC

Substantially Equivalent

510(k) numberK140134

Submission

Device name
Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece
Applicant
Starboard Medical, LLC
Yorba Linda, CA, US
Received
January 17, 2014
Decision date
June 16, 2014
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

Other 510(k)s with product code BZT

510(k)DeviceApplicantDecision
K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043…BZT · Traditional Covidien, LLC12/29/2025SE
K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional Deroyal Industries, Inc.04/02/2020SE
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
K062020Lifesound Esophageal StethoscopeBZT · Traditional Novamed, LLC09/05/2006SE
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.

510(k)DeviceDecision
K111050Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with…BZT · Traditional 04/12/2012SE
K111282Disposable Temperature Probes / Sensors and Interconnect Instrument CablesFLL · Traditional 08/11/2011SE

Questions and answers

When was Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece cleared by the FDA?

Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece (K140134) received a 510(k) decision of Substantially Equivalent on June 16, 2014, 150 days after the submission was received.

What is the product code of K140134?

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