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
- K242809Ascent Cardiorespiratory Diagnostic Software2Cleared 510(K)
- K223629SpiroSphere, SpiroSphereECG, CardioSphere2Cleared 510(K)
- K231561Pulmonary Function Tester, Model: A92Cleared 510(K)
- K222982Virtus Metabolic Monitor2Cleared 510(K)
- K221030Model 9100 PFT/DICO2Cleared 510(K)
- K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU2Cleared 510(K)
- K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors2Cleared 510(K)
- K181912Ascent Cardiorespiratory Diagnostic Software2Cleared 510(K)
- K173937SpiroSphere2Cleared 510(K)
- K161534EasyOne Pro Respiratory Analysis System2Cleared 510(K)
- K150888Shape-HF Cardiopulmonary Testing System2Cleared 510(K)
- K122699SENTRYSUITE PRODUCT LINE2Cleared 510(K)
- K120635EASYONE PRO RESPIRATORY TESTING DEVICE2Cleared 510(K)
- K113813SENTRYSUITE PRODUCT LINE2Cleared 510(K)
- K111053SENTRYSUITE PRODUCT LINE2Cleared 510(K)
- K091428EASYONE PRO RESPIRATORY ANALYSIS SYSTEM2Cleared 510(K)
- K090722SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM2Cleared 510(K)
- K082539MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT2Cleared 510(K)
- K080510VIP PULMONARY FUNCTION SYSTEM2Cleared 510(K)
- K080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT2Cleared 510(K)
- K071753MASTERSCREEN PNEUMO & MASTERSCOPE2Cleared 510(K)
- K062011MODIFICATION TO FLOWSCREEN2Cleared 510(K)
- K040549COSMED PONY FX2Cleared 510(K)
- K031194SPIROSOFT2Cleared 510(K)
- K020745COSMED MICROQUARK2Cleared 510(K)
- K993641METALYZER, MODEL 2; METALYZER, MODEL 32Cleared 510(K)
- K000648SPIRO PRO2Cleared 510(K)
- K981366STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES2Cleared 510(K)
- K980094MODIFICATION TO THE OXYCONALPHA2Cleared 510(K)
- K961252DSXL DIFFUSION SPIROMETER2Cleared 510(K)
- K942230OXYCON-ALPHA2Cleared 510(K)
- K942211VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS2Cleared 510(K)
- K933839MASTER SCREEN PNUEMO2Cleared 510(K)
- K932744FLOWSCREEN2Cleared 510(K)
- K933511UPGRADED SPIROMETER ST-902Cleared 510(K)
- K932278PFM PROFESSIONAL 7000 SPIROMETER2Cleared 510(K)
- K921309MODEL 508 PATIENT MONITOR2Cleared 510(K)
- K930085VITALOGRAPH DATA STORAGE SPIROMETER2Cleared 510(K)
- K911358CMD/DLCO DIAGNOSTIC SPIROMETER2Cleared 510(K)
- K892705EBS2605 INFANT HUGGER2Cleared 510(K)
- K894667MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP2Cleared 510(K)
- K883008PULMONARY FORCED FLOW SYSTEM (PUFFS)2Cleared 510(K)
- K881122UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.2Cleared 510(K)
- K864836L.A.P. SPIROMETER2Cleared 510(K)
- K864087PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM2Cleared 510(K)
- K863087SPIROLOOP-PULMONARY EXERCISE SYSTEM2Cleared 510(K)
- K861487ST-90 SPIRO ANALIZER2Cleared 510(K)
- K861486SPIROMETRY MODULE2Cleared 510(K)
- K855068SPIROMETER, MODEL TS-500 PART #SLZ75342Cleared 510(K)
- K855069SPIROMETER TS-400 SLZ 75472Cleared 510(K)
- K854745CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM2Cleared 510(K)
- K853433ELF2Cleared 510(K)
- K850045SPIROMETRICS 2453 & SMI III2Cleared 510(K)
- K823771SPIROTECH 3002Cleared 510(K)
- K823683VITALOGRAPH PFT PRINTER2Cleared 510(K)
- K821712INFORMED REMOTE FIELD UNIT MODEL IFM10002Cleared 510(K)
- K812850PTT-200 PULMONARY RECEIVER/MICROPROCES2Cleared 510(K)
- K812849PTT-200 TELEPHONIC PULMONARY TRANSMITT2Cleared 510(K)
- K812792PFT SCREENER (SYSTEM 1100)2Cleared 510(K)
- K810712ELECTRONIC SPIROMETER MODEL MFR-81002Cleared 510(K)
- K803053APEXLINE OF PULMONARY FUNCT. INSTRUM.2Cleared 510(K)
- K790579MEDISTOR II2Cleared 510(K)
- K780584PULMONARY FUNCTION TESTER2Cleared 510(K)
- 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
- 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 B—Neurological Diagnostic DevicesCFR Sub-Part
- 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
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- General HospitalReview Panel
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- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- Medical GeneticsReview Panel
- UnknownReview Panel
Shape-HF Cardiopulmonary Testing System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150888
- 510(k) Type
- Traditional
- Applicant
- SHAPE MEDICAL SYSTEMS, INC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/21/2016
- Days to Decision
- 294 days
- Submission Type
- Summary