FDA 510(k) Applications for Medical Device Product Code "BZT"
(Stethoscope, Esophageal, With Electrical Conductors)

FDA 510(k) Number Applicant Device Name Decision Date
K961060 ARISTO MEDICAL PRODUCTS, INC. ARISTO ESOPHAGEAL STETHOSCOPE 06/19/1996
K973839 CATHETER RESEARCH, INC. DISPOSABLE ESOPHAGEAL STETHOSCOPE 03/19/1998
K072621 CINCINNATI SUB-ZERO PRODUCTS, INC ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR 12/13/2007
K193027 DeRoyal Industries, Inc. Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French 04/02/2020
K062020 NOVAMED, LLC LIFESOUND ESOPHAGEAL STETHOSCOPE 09/05/2006
K982193 SHORE MEDICAL, INC. ESOPHAGEAL STETHOSCOPE 09/01/1998
K111050 STARBOARD MEDICAL, LLC ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR 04/12/2012
K140134 STARBOARD MEDICAL, LLC ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE 06/16/2014
K092716 TRUER MEDICAL INC. ESOPHAGEAL STETHOSCOPE 09/17/2009


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