Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- BSEAnalyzer, Gas, Helium, Gaseous-Phase2Product Code
- BSIAlgesimeter, Powered2Product Code
- BTYCalculator, Predicted Values, Pulmonary Function2Product Code
- BXAAnalyzer, Gas, Water Vapor, Gaseous-Phase1Product Code
- BXLAlgesimeter, Manual1Product Code
- BXQRhinoanemometer (Measurement Of Nasal Decongestion)2Product Code
- BXRMeter, Airway Pressure (Inspiratory Force)2Product Code
- BXWCalibrator, Volume, Gas1Product Code
- BZCCalculator, Pulmonary Function Data2Product Code
- BZGSpirometer, Diagnostic2Product Code
- BZHMeter, Peak Flow, Spirometry2Product Code
- BZKSpirometer, Monitoring (W/Wo Alarm)2Product Code
- BZLComputer, Oxygen-Uptake2Product Code
- BZMCalculator, Pulmonary Function Interpretor (Diagnostic)2Product Code
- BZSStethoscope Head1Product Code
- BZTStethoscope, Esophageal, With Electrical Conductors2Product Code
- K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French2Cleared 510(K)
- K140134ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE2Cleared 510(K)
- K111050ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR2Cleared 510(K)
- K092716ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K072621ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR2Cleared 510(K)
- K062020LIFESOUND ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K982193ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K973839DISPOSABLE ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K961060ARISTO ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K953793INTROSCOPE2Cleared 510(K)
- K930929ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K943495DISPOSABLE ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K940169DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K925789DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K930533BNOS MICROVENT(TM), MODEL AC AND MODEL AO2Cleared 510(K)
- K922007YSI MODEL 441A AIRWAY TEMPERATURE PROBE2Cleared 510(K)
- K904943TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE2Cleared 510(K)
- K894757T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE2Cleared 510(K)
- K893409YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP2Cleared 510(K)
- K885347VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K882319TELEMETRIC STETHOSCOPE2Cleared 510(K)
- K881293SHERIDAN ELECTROSURGERY PROTECTION FILTER2Cleared 510(K)
- K874295ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS2Cleared 510(K)
- K873344ESOPHAGEAL STETHOSCOPE W/THERMISTOR2Cleared 510(K)
- K870255MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)2Cleared 510(K)
- K864858LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR2Cleared 510(K)
- K864043ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T2Cleared 510(K)
- K862672ESOPHAGEAL STETHOSCOPE WITH THERMISTOR2Cleared 510(K)
- K862548TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER2Cleared 510(K)
- K862131SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR2Cleared 510(K)
- K861541SHERIDAN - YSI/ECG SONATEMP (TM)2Cleared 510(K)
- K854212ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR2Cleared 510(K)
- K852228ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS2Cleared 510(K)
- K844055ESOPHAGEAL STETHO SCOPE2Cleared 510(K)
- K843071ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR2Cleared 510(K)
- K842309VITACOMM 100 ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K841098SHERIDAN YSI/SONATEMP2Cleared 510(K)
- K830716CARDIO-ESOPHASCOPE2Cleared 510(K)
- K823743MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO2Cleared 510(K)
- K821890CRITIKON #817 ESOPHAGEAL MULTI-PROBE2Cleared 510(K)
- K812976ARGYLE ACC-U-THERM W/TEMPERATURE PROBE2Cleared 510(K)
- K811928LIFESOUND ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K811862HI-LO TEMP ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K810147ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE2Cleared 510(K)
- K791190STETHOSCOPE WITH TEMPERATURE SENSOR2Cleared 510(K)
- BZWStethoscope, Esophageal1Product Code
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)2Product Code
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)2Product Code
- CBTArterial Blood Sampling Kit1Product Code
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling2Product Code
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling2Product Code
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling2Product Code
- CCIAnalyzer, Gas, Nitrogen, Gaseous-Phase2Product Code
- CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase2Product Code
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2Product Code
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase2Product Code
- CCMPlethysmograph, Pressure2Product Code
- JEDAnalyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling3Product Code
- JEFAnalyzer, Gas, Neon, Gaseous-Phase2Product Code
- JEGAnalyzer, Gas, Argon, Gaseous-Phase2Product Code
- JEHPlethysmograph, Volume2Product Code
- JFEValve, Switching (Ploss)1Product Code
- KGKGas, Collecting Vessel1Product Code
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- OFZBlood Specimen Collection Kit (Excludes Hiv Testing)1Product Code
- PNVImpedance Measuring Device Utilizing Oscillation Techniques2Product Code
- OGKOrotracheal Intubation Guide Kit2Product Code
- PHZAbnormal Breath Sound Device2Product Code
- QEBVentilatory Electrical Impedance Tomograph2Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
- Page Type
- Cleared 510(K)
- 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