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
K904943 ARZCO MEDICAL ELECTRONICS, INC. TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE 04/26/1991
K811928 BIOMEDICAL CONCEPTS, INC. LIFESOUND ESOPHAGEAL STETHOSCOPE 07/28/1981
K864858 BIOMEDICAL CONCEPTS, INC. LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR 03/10/1987
K930533 BNOS MEDITECH, LTD. BNOS MICROVENT(TM), MODEL AC AND MODEL AO 03/29/1993
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
K930929 COAST MEDICAL CORP. ESOPHAGEAL STETHOSCOPE 03/17/1995
K943495 COAST MEDICAL, INC. DISPOSABLE ESOPHAGEAL STETHOSCOPE 09/08/1994
K821890 CRITIKON COMPANY,LLC CRITIKON #817 ESOPHAGEAL MULTI-PROBE 08/03/1982
K925789 DEROYAL INDUSTRIES, INC. DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE 07/13/1993
K940169 DEROYAL INDUSTRIES, INC. DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE 07/28/1994
K862672 INMED CORP. ESOPHAGEAL STETHOSCOPE WITH THERMISTOR 10/27/1986
K862131 K & S MEDICORP SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR 07/14/1986
K862548 LAWRENCE MEDICAL SYSTEMS, INC. TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER 10/22/1986
K894757 LOUISVILLE LABORATORIES, INC. T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE 09/18/1989
K811862 MALLINCKRODT CRITICAL CARE HI-LO TEMP ESOPHAGEAL STETHOSCOPE 07/10/1981
K873344 MEDICAL COMPONENTS, INC. ESOPHAGEAL STETHOSCOPE W/THERMISTOR 10/20/1987
K791190 NATIONAL CATHETER CO. DIV. MALLINCKRODT STETHOSCOPE WITH TEMPERATURE SENSOR 07/06/1979
K062020 NOVAMED, LLC LIFESOUND ESOPHAGEAL STETHOSCOPE 09/05/2006
K953793 POLAMEDCO, INC. INTROSCOPE 11/29/1995
K830716 PORTEX, INC. CARDIO-ESOPHASCOPE 08/12/1983
K810147 PORTEX, INC. ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE 02/05/1981
K843071 PRIMROSE MEDICAL, INC. ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR 08/24/1984
K854212 RESPIRATORY SUPPORT PRODUCTS, INC. ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR 01/03/1986
K864043 RESPIRATORY SUPPORT PRODUCTS, INC. ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE "T" 12/15/1986
K844055 SENSORTEK, INC. ESOPHAGEAL STETHO SCOPE 10/25/1984
K852228 SENSORTEK, INC. ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS 09/03/1985
K874295 SHERIDAN CATHETER CORP. ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS 11/24/1987
K861541 SHERIDAN CATHETER CORP. SHERIDAN - YSI/ECG SONATEMP (TM) 06/16/1986
K881293 SHERIDAN CATHETER CORP. SHERIDAN ELECTROSURGERY PROTECTION FILTER 06/16/1988
K841098 SHERIDAN CATHETER CORP. SHERIDAN YSI/SONATEMP 04/30/1984
K812976 SHERWOOD MEDICAL CO. ARGYLE ACC-U-THERM W/TEMPERATURE PROBE 12/08/1981
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
K870255 TRANSCOR, INC. MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM) 03/26/1987
K092716 TRUER MEDICAL INC. ESOPHAGEAL STETHOSCOPE 09/17/2009
K842309 VITACOMM, INC. VITACOMM 100 ESOPHAGEAL STETHOSCOPE 06/22/1984
K885347 VITACOMM, INC. VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE 01/30/1989
K882319 VITAL SIGNS, INC. TELEMETRIC STETHOSCOPE 08/02/1988
K823743 Y MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO 01/18/1983
K922007 YELLOW SPRINGS INSTRUMENT CO., INC. YSI MODEL 441A AIRWAY TEMPERATURE PROBE 11/04/1992
K893409 YELLOW SPRINGS INSTRUMENT CO., INC. YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP 07/20/1989


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