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
- 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
- K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM1Cleared 510(K)
- K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEM1Cleared 510(K)
- K955663ABC IN-LINE BLOOD SAMPLING KIT1Cleared 510(K)
- K954015ABG POINT LOK NEEDLE PROTECTION DEVICE1Cleared 510(K)
- K954035ACTI-FLEX ARTERIAL EXTENSION SET1Cleared 510(K)
- K950098NEEDLE SAFETY COVER1Cleared 510(K)
- K945719ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM1Cleared 510(K)
- K944941PISTON SYRINGE1Cleared 510(K)
- K945485ABG NEEDLE PROTECTION1Cleared 510(K)
- K940575ASPIR-PULSE(TM) SAF-T-VENT1Cleared 510(K)
- K931873VACVENT1Cleared 510(K)
- K930986BLOOD GAS KIT (NON-STERILE) REORDER NO. 05601Cleared 510(K)
- K925453SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I1Cleared 510(K)
- K930471SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II1Cleared 510(K)
- K930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS1Cleared 510(K)
- K914778NEOLINE(TM)1Cleared 510(K)
- K912043ACCU-VENT(TM) WITH NEEDLE-PRO(TM)1Cleared 510(K)
- K905464MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING1Cleared 510(K)
- K902881LAB-SITE SAFETY NEEDLE1Cleared 510(K)
- K902632GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS1Cleared 510(K)
- K900302UMBILICAL CORD BLOOD SAMPLING KIT1Cleared 510(K)
- K897133MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT1Cleared 510(K)
- K895171BLOOD GAS SAFETY SYRINGE1Cleared 510(K)
- K875117CIBA CORNING BALANCED HEPARIN FOR CA++1Cleared 510(K)
- K872244CORD-ASSURE UMBILICAL BLOOD GAS KIT1Cleared 510(K)
- K870720AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE1Cleared 510(K)
- K844615BIOSAMPLER1Cleared 510(K)
- K843360ARTAP ARTERIAL BLOOD SAMPLING DEVICE1Cleared 510(K)
- K842008MARQUEST MICRO STIK 9000 SERIES1Cleared 510(K)
- K841486ARTERIAL BLOOD SAMPLING KITS1Cleared 510(K)
- K840986PREFILLED PULSATOR SYRINGE1Cleared 510(K)
- K840987VAPORIZED HEPARIN1Cleared 510(K)
- K833923MARZ-175 ARTERIAL BLOOD GAS SYRINGE1Cleared 510(K)
- K833582PULSATOR ARTERIAL BLOOD SAMPLING SYRIN1Cleared 510(K)
- K832545ARTERIAL BLOOD SAMPLING KIT1Cleared 510(K)
- K830312ASPIRATOR1Cleared 510(K)
- K830310OMNISTICK1Cleared 510(K)
- K830311AUTO STIK1Cleared 510(K)
- K831034QUALISTICK ARTERIAL BLOOD SAMPLER1Cleared 510(K)
- K830333ABG KITS - CMS 4000 SERIES1Cleared 510(K)
- K822786MDM ARTERIAL BLOOD GAS KIT1Cleared 510(K)
- K822248DESERET ARTERIAL BLOOD SAMPLING KIT1Cleared 510(K)
- K821406ARTERIAL BLOOD SAMPLING KIT1Cleared 510(K)
- K820875AUTOSTIK1Cleared 510(K)
- K812338PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY1Cleared 510(K)
- K811860EASY-FLO ARTERIAL BLOOD GAS KIT1Cleared 510(K)
- K811199MARZ-1751Cleared 510(K)
- K801620ASPIRATOR1Cleared 510(K)
- K801435ORGANON ARTERIAL BLOOD SAMPLER1Cleared 510(K)
- K801146SAMPLING KIT1Cleared 510(K)
- K800860OMNISTIK, MQ 501GS1Cleared 510(K)
- K791465MOSQUITO ARTERIAL BLOOD SAMPLER1Cleared 510(K)
- K790196MONOJECT ARTERIAL BLOOD SAMPLING DEVICE1Cleared 510(K)
- K781857TRAY, ARTERIAL BLOOD GAS SAMPLING1Cleared 510(K)
- K781616OMNI STIK1Cleared 510(K)
- K780939BARD-PARKER ARTERIAL MONITORING SYSTEM1Cleared 510(K)
- K771975ARTERIAL BLOOD SAMPLING TRAY1Cleared 510(K)
- K771013MOSQUITO1Cleared 510(K)
- 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
BIOSAMPLER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K844615
- 510(k) Type
- Traditional
- Applicant
- BIOTEK-CARIBBEAN
- Country
- Dominican Republic
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/21/1985
- Days to Decision
- 114 days