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
- K192584BEACON Caresystem Model 000021442Cleared 510(K)
- K192595ExSpiron 2Xi2Cleared 510(K)
- K180788Gas Module 32Cleared 510(K)
- K173181ExSpiron 1Xi2Cleared 510(K)
- K162131ExSpiron 1Xi2Cleared 510(K)
- K130170EXSPIRON 1XI2Cleared 510(K)
- K120087EXSPIRON2Cleared 510(K)
- K103578PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST2Cleared 510(K)
- K091853WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-0142Cleared 510(K)
- K092217MERCURY VCO22Cleared 510(K)
- K091459PHILIPS NM3 MONITOR, MODEL 79002Cleared 510(K)
- K080652MERCURY VCO2 MODULE WITH CAPNOSTAT 52Cleared 510(K)
- K062754GAS MODULE SE, MODEL 0998-00-0481-022Cleared 510(K)
- K051279CALDYNE, INC. EXHALOMETER EX100, MODEL EX1002Cleared 510(K)
- K983274STARTRACK INFANT GRAPHICS MONITOR2Cleared 510(K)
- K972086ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3112Cleared 510(K)
- K932098CAPNOMAC ULTIMA ANESTHESIA MONITOR2Cleared 510(K)
- K931542NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR2Cleared 510(K)
- K921717BICORE SMARTVALVE OCCLUSION VALVE2Cleared 510(K)
- K903674MODEL 295 ELECTRONIC RESPIROMETER2Cleared 510(K)
- K903959NEONATAL METASCOPE2Cleared 510(K)
- K901885PARTNER VOLUME MONITOR2Cleared 510(K)
- K890932CAV 3.0C SOFTWARE PROGRAM2Cleared 510(K)
- K884910MODEL 1010, CY-MET2Cleared 510(K)
- K884959RESPITRAK2Cleared 510(K)
- K884942MONAGHAN RVM, MODEL 7612Cleared 510(K)
- K890724MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR2Cleared 510(K)
- K872660BEAR NVM-12Cleared 510(K)
- K864886RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL2Cleared 510(K)
- K863866RESPIRADYNE II(TM)2Cleared 510(K)
- K863538RESPICENTRAL(TM)2Cleared 510(K)
- K862688OHMEDA 5420 VOLUME MONITOR2Cleared 510(K)
- K862687OHMEDA 5410 VOLUME MONITOR2Cleared 510(K)
- K854956RESPIGRAPH2Cleared 510(K)
- K853346BEAR NICU-12Cleared 510(K)
- K852692RESPITRACE 300SC2Cleared 510(K)
- K843799OHMEDA RM311 RESPIROMETER2Cleared 510(K)
- K843800OHMEDA RM121 RESPIROMETER2Cleared 510(K)
- K840975RICO RESPIRATION MONITOR2Cleared 510(K)
- K840453MEDISHIELD PVM RESPIROMETER2Cleared 510(K)
- K823780RESPITRACE 300SC2Cleared 510(K)
- K823783RESPICOMB2Cleared 510(K)
- K832565OHIO 5400 VOLUME MONITOR2Cleared 510(K)
- K822689PORTABLE MONITORING & SCREENING SPIROM.2Cleared 510(K)
- K831237SPIROMED RESPIROMETER2Cleared 510(K)
- K830995POCKET SPIROMETER2Cleared 510(K)
- K823782RESPITRACE SYSTEM2Cleared 510(K)
- K823922COMPUTERIZED SPIROMETRY SYSTEM2Cleared 510(K)
- K823555MAGTARAK RESPIRATORY MONITOR & FLOW SENS2Cleared 510(K)
- K822912BEAR VM-90 VENTILATION MONITOR2Cleared 510(K)
- K812956SPIROX H2Cleared 510(K)
- K812959SPIROX A2Cleared 510(K)
- K812046TIDAL VOLUME MONITOR 1502Cleared 510(K)
- K800086RMS 111F RESPIRATORY MONITORING SYSTEM2Cleared 510(K)
- K792573ALARM USED W/MONITORING SPIROMETER2Cleared 510(K)
- K792572EMPIRE SPIROMETER2Cleared 510(K)
- K782145SPIROMETER, MINI POSITIVE2Cleared 510(K)
- K780064SPIROMETER, MONITORING W/ALARM2Cleared 510(K)
- K772016RESPITRACE2Cleared 510(K)
- K770907SPIROMETEO EXHAUST2Cleared 510(K)
- K760971POSITIVE DISPLACEMENT SPIROMETER2Cleared 510(K)
- 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
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K051279
- 510(k) Type
- Traditional
- Applicant
- CALDYNE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/7/2005
- Days to Decision
- 113 days
- Submission Type
- Summary