FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
BSE
Analyzer, Gas, Helium, Gaseous-Phase
2
Product Code
BSI
Algesimeter, Powered
2
Product Code
BTY
Calculator, Predicted Values, Pulmonary Function
2
Product Code
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
1
Product Code
BXL
Algesimeter, Manual
1
Product Code
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
2
Product Code
BXR
Meter, Airway Pressure (Inspiratory Force)
2
Product Code
BXW
Calibrator, Volume, Gas
1
Product Code
BZC
Calculator, Pulmonary Function Data
2
Product Code
BZG
Spirometer, Diagnostic
2
Product Code
BZH
Meter, Peak Flow, Spirometry
2
Product Code
BZK
Spirometer, Monitoring (W/Wo Alarm)
2
Product Code
BZL
Computer, Oxygen-Uptake
2
Product Code
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
2
Product Code
BZS
Stethoscope Head
1
Product Code
BZT
Stethoscope, Esophageal, With Electrical Conductors
2
Product Code
K
19
3027
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
2
Cleared 510(K)
K
14
0134
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
2
Cleared 510(K)
K
11
1050
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
2
Cleared 510(K)
K
09
2716
ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
07
2621
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
2
Cleared 510(K)
K
06
2020
LIFESOUND ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
98
2193
ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
97
3839
DISPOSABLE ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
96
1060
ARISTO ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
95
3793
INTROSCOPE
2
Cleared 510(K)
K
93
0929
ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
94
3495
DISPOSABLE ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
94
0169
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
92
5789
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
93
0533
BNOS MICROVENT(TM), MODEL AC AND MODEL AO
2
Cleared 510(K)
K
92
2007
YSI MODEL 441A AIRWAY TEMPERATURE PROBE
2
Cleared 510(K)
K
90
4943
TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
2
Cleared 510(K)
K
89
4757
T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
2
Cleared 510(K)
K
89
3409
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
2
Cleared 510(K)
K
88
5347
VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
88
2319
TELEMETRIC STETHOSCOPE
2
Cleared 510(K)
K
88
1293
SHERIDAN ELECTROSURGERY PROTECTION FILTER
2
Cleared 510(K)
K
87
4295
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
2
Cleared 510(K)
K
87
3344
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
2
Cleared 510(K)
K
87
0255
MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)
2
Cleared 510(K)
K
86
4858
LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR
2
Cleared 510(K)
K
86
4043
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
2
Cleared 510(K)
K
86
2672
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
2
Cleared 510(K)
K
86
2548
TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
2
Cleared 510(K)
K
86
2131
SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR
2
Cleared 510(K)
K
86
1541
SHERIDAN - YSI/ECG SONATEMP (TM)
2
Cleared 510(K)
K
85
4212
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
2
Cleared 510(K)
K
85
2228
ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
2
Cleared 510(K)
K
84
4055
ESOPHAGEAL STETHO SCOPE
2
Cleared 510(K)
K
84
3071
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
2
Cleared 510(K)
K
84
2309
VITACOMM 100 ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
84
1098
SHERIDAN YSI/SONATEMP
2
Cleared 510(K)
K
83
0716
CARDIO-ESOPHASCOPE
2
Cleared 510(K)
K
82
3743
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
2
Cleared 510(K)
K
82
1890
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
2
Cleared 510(K)
K
81
2976
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
2
Cleared 510(K)
K
81
1928
LIFESOUND ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
81
1862
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
2
Cleared 510(K)
K
81
0147
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
2
Cleared 510(K)
K
79
1190
STETHOSCOPE WITH TEMPERATURE SENSOR
2
Cleared 510(K)
BZW
Stethoscope, Esophageal
1
Product Code
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
2
Product Code
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
2
Product Code
CBT
Arterial Blood Sampling Kit
1
Product Code
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
2
Product Code
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
2
Product Code
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
2
Product Code
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
2
Product Code
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
2
Product Code
CCM
Plethysmograph, Pressure
2
Product Code
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
3
Product Code
JEF
Analyzer, Gas, Neon, Gaseous-Phase
2
Product Code
JEG
Analyzer, Gas, Argon, Gaseous-Phase
2
Product Code
JEH
Plethysmograph, Volume
2
Product Code
JFE
Valve, Switching (Ploss)
1
Product Code
KGK
Gas, Collecting Vessel
1
Product Code
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
1
Product Code
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
2
Product Code
OGK
Orotracheal Intubation Guide Kit
2
Product Code
PHZ
Abnormal Breath Sound Device
2
Product Code
QEB
Ventilatory Electrical Impedance Tomograph
2
Product Code
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-b—diagnostic-devices
/
BZT
/
K843071
View Source
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843071
510(k) Type
Traditional
Applicant
PRIMROSE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/24/1984
Days to Decision
18 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
BSE
Analyzer, Gas, Helium, Gaseous-Phase
BSI
Algesimeter, Powered
BTY
Calculator, Predicted Values, Pulmonary Function
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
BXL
Algesimeter, Manual
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
BXR
Meter, Airway Pressure (Inspiratory Force)
BXW
Calibrator, Volume, Gas
BZC
Calculator, Pulmonary Function Data
BZG
Spirometer, Diagnostic
BZH
Meter, Peak Flow, Spirometry
BZK
Spirometer, Monitoring (W/Wo Alarm)
BZL
Computer, Oxygen-Uptake
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
BZS
Stethoscope Head
BZT
Stethoscope, Esophageal, With Electrical Conductors
K
19
3027
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K
14
0134
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
K
11
1050
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
K
09
2716
ESOPHAGEAL STETHOSCOPE
K
07
2621
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
K
06
2020
LIFESOUND ESOPHAGEAL STETHOSCOPE
K
98
2193
ESOPHAGEAL STETHOSCOPE
K
97
3839
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K
96
1060
ARISTO ESOPHAGEAL STETHOSCOPE
K
95
3793
INTROSCOPE
K
93
0929
ESOPHAGEAL STETHOSCOPE
K
94
3495
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K
94
0169
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
K
92
5789
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
K
93
0533
BNOS MICROVENT(TM), MODEL AC AND MODEL AO
K
92
2007
YSI MODEL 441A AIRWAY TEMPERATURE PROBE
K
90
4943
TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
K
89
4757
T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
K
89
3409
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
K
88
5347
VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
K
88
2319
TELEMETRIC STETHOSCOPE
K
88
1293
SHERIDAN ELECTROSURGERY PROTECTION FILTER
K
87
4295
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
K
87
3344
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K
87
0255
MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)
K
86
4858
LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K
86
4043
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
K
86
2672
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
K
86
2548
TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
K
86
2131
SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR
K
86
1541
SHERIDAN - YSI/ECG SONATEMP (TM)
K
85
4212
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
K
85
2228
ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
K
84
4055
ESOPHAGEAL STETHO SCOPE
K
84
3071
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
K
84
2309
VITACOMM 100 ESOPHAGEAL STETHOSCOPE
K
84
1098
SHERIDAN YSI/SONATEMP
K
83
0716
CARDIO-ESOPHASCOPE
K
82
3743
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K
82
1890
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
K
81
2976
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K
81
1928
LIFESOUND ESOPHAGEAL STETHOSCOPE
K
81
1862
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K
81
0147
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K
79
1190
STETHOSCOPE WITH TEMPERATURE SENSOR
BZW
Stethoscope, Esophageal
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CBT
Arterial Blood Sampling Kit
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
CCM
Plethysmograph, Pressure
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
JEF
Analyzer, Gas, Neon, Gaseous-Phase
JEG
Analyzer, Gas, Argon, Gaseous-Phase
JEH
Plethysmograph, Volume
JFE
Valve, Switching (Ploss)
KGK
Gas, Collecting Vessel
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
OGK
Orotracheal Intubation Guide Kit
PHZ
Abnormal Breath Sound Device
QEB
Ventilatory Electrical Impedance Tomograph
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-b—diagnostic-devices
/
BZT
/
K843071
View Source
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843071
510(k) Type
Traditional
Applicant
PRIMROSE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/24/1984
Days to Decision
18 days