Product code BZT

Device name: Stethoscope, Esophageal, With Electrical Conductors
Medical specialty: Anesthesiology
Device class: 2
Regulation number: 868.1920
Review panel: AN
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K251025	Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)	Covidien, LLC	2025-12-29
K193027	Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French	Deroyal Industries, Inc.	2020-04-02
K140134	ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE	Starboard Medical, LLC	2014-06-16
K111050	ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR	Starboard Medical, LLC	2012-04-12
K092716	ESOPHAGEAL STETHOSCOPE	Truer Medical, Inc.	2009-09-17
K072621	ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR	Cincinnati Sub-Zero Products, Inc.	2007-12-13
K062020	LIFESOUND ESOPHAGEAL STETHOSCOPE	Novamed, LLC	2006-09-05
K982193	ESOPHAGEAL STETHOSCOPE	Shore Medical, Inc.	1998-09-01
K973839	DISPOSABLE ESOPHAGEAL STETHOSCOPE	Catheter Research, Inc.	1998-03-19
K961060	ARISTO ESOPHAGEAL STETHOSCOPE	Aristo Medical Products, Inc.	1996-06-19
K953793	INTROSCOPE	Polamedco, Inc.	1995-11-29
K930929	ESOPHAGEAL STETHOSCOPE	Coast Medical Corp.	1995-03-17
K943495	DISPOSABLE ESOPHAGEAL STETHOSCOPE	Coast Medical, Inc.	1994-09-08
K940169	DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE	Deroyal Industries, Inc.	1994-07-28
K925789	DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE	Deroyal Industries, Inc.	1993-07-13
K930533	BNOS MICROVENT(TM), MODEL AC AND MODEL AO	Bnos Meditech, Ltd.	1993-03-29
K922007	YSI MODEL 441A AIRWAY TEMPERATURE PROBE	Yellow Springs Instrument Co., Inc.	1992-11-04
K904943	TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE	Arzco Medical Electronics, Inc.	1991-04-26
K894757	T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE	Louisville Laboratories, Inc.	1989-09-18
K893409	YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP	Yellow Springs Instrument Co., Inc.	1989-07-20
K885347	VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE	Vitacomm, Inc.	1989-01-30
K882319	TELEMETRIC STETHOSCOPE	Vital Signs, Inc.	1988-08-02
K881293	SHERIDAN ELECTROSURGERY PROTECTION FILTER	Sheridan Catheter Corp.	1988-06-16
K874295	ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS	Sheridan Catheter Corp.	1987-11-24
K873344	ESOPHAGEAL STETHOSCOPE W/THERMISTOR	Medical Components, Inc.	1987-10-20
K870255	MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)	Transcor, Inc.	1987-03-26
K864858	LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR	Biomedical Concepts, Inc.	1987-03-10
K864043	ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T	Respiratory Support Products, Inc.	1986-12-15
K862672	ESOPHAGEAL STETHOSCOPE WITH THERMISTOR	Inmed Corp.	1986-10-27
K862548	TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER	Lawrence Medical Systems, Inc.	1986-10-22

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10884521820890	Mon-a-Therm	Covidien LP	2023-05-29
10884521820906	Mon-a-Therm	Covidien LP	2023-05-29
10884521820913	Mon-a-Therm	Covidien LP	2023-05-29
10884521820920	Mon-a-Therm	Covidien LP	2023-05-29
10080196551606	Medline	MEDLINE INDUSTRIES, INC.	2022-09-02
30695085000321	Level 1	ICU MEDICAL, INC.	2016-12-15
10080196551774	Medline	MEDLINE INDUSTRIES, INC.	2016-10-14
30695085000376	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000369	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000352	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000338	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000314	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000307	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000291	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000284	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000277	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000260	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000253	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000246	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000239	Level 1	ICU MEDICAL, INC.	2016-10-14
30695085000222	Level 1	ICU MEDICAL, INC.	2016-10-14
15019517059205	Level 1	ICU MEDICAL, INC.	2016-10-14
10351688435279	Portex	ICU MEDICAL, INC.	2016-10-05
20884521031743	Mon-a-Therm	Covidien LP	2016-09-24
20884521031736	Mon-a-Therm	Covidien LP	2016-09-24
20884521031729	Mon-a-Therm	Covidien LP	2016-09-24
20884521031712	Mon-a-Therm	Covidien LP	2016-09-24
00749756045827	DeRoyal	DEROYAL INDUSTRIES, INC.	2016-09-12
00749756045834	DeRoyal	DEROYAL INDUSTRIES, INC.	2016-09-12
00749756045841	DeRoyal	DEROYAL INDUSTRIES, INC.	2016-09-12

Product code BZT

Related 510(k) Records#

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