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
- K183567Vyntus/SentrySuite Product Line2Cleared 510(K)
- K190853Vyntus BODY2Cleared 510(K)
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART2Cleared 510(K)
- K162515COSMED K5 Wearable Metabolic Technology2Cleared 510(K)
- K161295MiniBox +2Cleared 510(K)
- K150810Vyntus / SentrySuite Product Line2Cleared 510(K)
- K133925VYNTUS/ SENTRYSUITE PRODUCT LINE2Cleared 510(K)
- K133051PULMONE MINIBOX PFT TM2Cleared 510(K)
- K102047LCI OPTION FOR INNOCOR2Cleared 510(K)
- K072323MASTERSCREEN & OXYCON CPX2Cleared 510(K)
- K052328ZAN LUNG-FUNCTION LAB2Cleared 510(K)
- K040698MASTERSCREEN CPX AND OXYCON CPX2Cleared 510(K)
- K023120OXYCON MOBILE2Cleared 510(K)
- K011344INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 0044002Cleared 510(K)
- K001631CORTEX METAMAX2Cleared 510(K)
- K001174COSMED QUARK2Cleared 510(K)
- K001502AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO2Cleared 510(K)
- K992214OXYCON PRO2Cleared 510(K)
- K982499COSMO PLUS WITH NICO, MODEL 82002Cleared 510(K)
- K982487CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO2Cleared 510(K)
- K970840INTELLIFLOW RESPIRATORY ANALYZER2Cleared 510(K)
- K963373COSMED K42Cleared 510(K)
- K964360VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 1012Cleared 510(K)
- K954730BENCHMARK TRANSFER TEST2Cleared 510(K)
- K964939THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS2Cleared 510(K)
- K963380CO 2 SMO PLUS2Cleared 510(K)
- K960121AUTOLINK BODY PLETHYSMOGRAPH2Cleared 510(K)
- K953990TRANSFLOW TEST2Cleared 510(K)
- K960831VENTRAK RMMS 15502Cleared 510(K)
- K952542ACKRAD ESOPHAGEAL BALLOON CATHETER SET2Cleared 510(K)
- K946077DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS2Cleared 510(K)
- K951157DX1-PORTABLE2Cleared 510(K)
- K941843MMS-24002Cleared 510(K)
- K945213TEEN 1002Cleared 510(K)
- K942864LUNG DIFFUSION2Cleared 510(K)
- K935309LUNG DIFFUSION2Cleared 510(K)
- K921306ARGIS PULMONARY FUNCTION TESTING SYSTEM2Cleared 510(K)
- K915833SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART2Cleared 510(K)
- K915686MODEL 2900 METABOLIC MEASUREMENT CART2Cleared 510(K)
- K913681MULTISPIRO-BREEZE2Cleared 510(K)
- K905480SPIROSCOPE2Cleared 510(K)
- K900696BIORE CP-100 CARDIOPULMONARY MONITOR2Cleared 510(K)
- K895963MODIFIED STAR CALC2Cleared 510(K)
- K893845PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM2Cleared 510(K)
- K894839OS-1 OCCLUSION SYSTEM - 12Cleared 510(K)
- K892670PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)2Cleared 510(K)
- K892121SPIRO-LINK REAL TIME SPIROMETRY SYSTEM2Cleared 510(K)
- K881235Q-PLEX 12Cleared 510(K)
- K883732ARGIS PULMONARY FUNCTION TESTING SYSTEM2Cleared 510(K)
- K875027STAR CALC2Cleared 510(K)
- K861418SPINNAKER2Cleared 510(K)
- K860844VISTA INTERFACE SYSSTEM2Cleared 510(K)
- K854626COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B2Cleared 510(K)
- K853443ALVEO-DIFFUSION TEST2Cleared 510(K)
- K855070SPIROMETER MODEL TS-200 SLZ 75412Cleared 510(K)
- K852909MVP - 60002Cleared 510(K)
- K851805LPA-3 PRINTER2Cleared 510(K)
- K843860OXYSCREEN2Cleared 510(K)
- K843848AW TEST2Cleared 510(K)
- K843852APTA-BRONCHOSCREEN2Cleared 510(K)
- K843849PNEUMOSCREEN2Cleared 510(K)
- K842760LUNG ANALYZER CM-3102Cleared 510(K)
- K840711PULMONARY FUNCTION SYS-30002Cleared 510(K)
- K831777COLLINS DS2Cleared 510(K)
- K831778RS-RESIDUAL VOLUME SYSTEM2Cleared 510(K)
- K831779COLLINS EAGLE II2Cleared 510(K)
- K830954ACOH WELLNESS TESTER2Cleared 510(K)
- K822986PULMONARY FUNCTION LAB SYSTEM 10702Cleared 510(K)
- K812001OSCILLAIRE2Cleared 510(K)
- K810751PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF2Cleared 510(K)
- K802920INSPIRON PULMONARY FUNCTION ANALYZER2Cleared 510(K)
- K810243SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME2Cleared 510(K)
- K810196SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM2Cleared 510(K)
- K803255AUTOMATED PULMONARY FUNCTION LABORATORY2Cleared 510(K)
- K802928SPIROMETRIC COMPUTER #SC-102Cleared 510(K)
- K802116ANESTHESIA GAS MACHINE2Cleared 510(K)
- K801920SYSTEM 80 COMPUTERIZED SPIROMETER2Cleared 510(K)
- K801919SYSTEM 88 COMPUTERIZED DIFFUSION ANALY2Cleared 510(K)
- K801918SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO2Cleared 510(K)
- K801497INFANT VENTILATORY MEASUREMENT SYSTEM2Cleared 510(K)
- K801597PFT CALIBRATOR2Cleared 510(K)
- K801526SURVEYOR I, RESPIRATORY COMPUTER SYSTEM2Cleared 510(K)
- K801088F.R.C. APPARATUS2Cleared 510(K)
- K800547MEDISTOR III LUNG ANALYZER2Cleared 510(K)
- K791503VITALOGRAPH FUNCTION ANALYZER2Cleared 510(K)
- K790185MODEL V 4207 INTEGRATING PLUG-IN2Cleared 510(K)
- K780328PULMONARY FUNCTION TESTER, COMPUTERIZED2Cleared 510(K)
- K780322ANALYZER, PULMONARY FUNCTION2Cleared 510(K)
- K770532PC-30 PULMONARY COMPUTER2Cleared 510(K)
- 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
- 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
DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K946077
- 510(k) Type
- Traditional
- Applicant
- HANS RUDOLPH, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/15/1995
- Days to Decision
- 276 days
- Submission Type
- Statement