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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