Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—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
- BRWProtector, Dental1Product Code
- BSFAbsorber, Carbon-Dioxide1Product Code
- BSJMask, Gas, Anesthetic1Product Code
- BSKCuff, Tracheal Tube, Inflatable2Product Code
- BSNFilter, Conduction, Anesthetic2Product Code
- BSOCatheter, Conduction, Anesthetic2Product Code
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2Product Code
- BSRStylet, Tracheal Tube1Product Code
- BSZGas-Machine, Anesthesia2Product Code
- BTBHook, Ether1Product Code
- BTCBag, Reservoir1Product Code
- BTKStrap, Head, Gas Mask1Product Code
- BTLVentilator, Emergency, Powered (Resuscitator)2Product Code
- BTMVentilator, Emergency, Manual (Resuscitator)2Product Code
- BTOTube, Tracheostomy (W/Wo Connector)2Product Code
- BTPDropper, Ether1Product Code
- BTQAirway, Nasopharyngeal1Product Code
- BTRTube, Tracheal (W/Wo Connector)2Product Code
- BTSTube, Bronchial (W/Wo Connector)2Product Code
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2Product Code
- BWBForceps, Tube Introduction1Product Code
- BWCNeedle, Emergency Airway2Product Code
- BWFSpirometer, Therapeutic (Incentive)2Product Code
- BWLApparatus, Electronanesthesia3Product Code
- BYDCondenser, Heat And Moisture (Artificial Nose)1Product Code
- BYEAttachment, Breathing, Positive End Expiratory Pressure2Product Code
- BYFMask, Oxygen, Low Concentration, Venturi1Product Code
- BYGMask, Oxygen1Product Code
- BYHDrain, Tee (Water Trap)1Product Code
- BYIPercussor, Powered-Electric2Product Code
- BYJUnit, Liquid-Oxygen, Portable2Product Code
- BYKTent, Oxygen, Electrically Powered2Product Code
- BYLTent, Oxygen1Product Code
- BYNChair, Posture, For Cardiac And Pulmonary Treatment1Product Code
- BYOBottle, Blow1Product Code
- BYPMouthpiece, Breathing1Product Code
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)2Product Code
- BYWDevice, Rebreathing1Product Code
- BYXTubing, Pressure And Accessories1Product Code
- BZAConnector, Airway (Extension)1Product Code
- BZBCatheter, Nasal, Oxygen1Product Code
- BZDVentilator, Non-Continuous (Respirator)2Product Code
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- BZRMixer, Breathing Gases, Anesthesia Inhalation2Product Code
- CADVaporizer, Anesthesia, Non-Heated2Product Code
- CAEAirway, Oropharyngeal, Anesthesiology1Product Code
- CAFNebulizer (Direct Patient Interface)2Product Code
- CAGCirculator, Breathing-Circuit2Product Code
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1Product Code
- CALLaryngoscope, Non-Rigid1Product Code
- CAOAirway, Esophageal (Obturator)2Product Code
- CATCannula, Nasal, Oxygen1Product Code
- CAWGenerator, Oxygen, Portable2Product Code
- CAZAnesthesia Conduction Kit2Product Code
- K222341Arrow 0.2 Micron Flat Filter, GVS2Cleared 510(K)
- K210983BD Epilor Syringe2Cleared 510(K)
- K201356Plastic LOR Syringe2Cleared 510(K)
- K202699E-Cath STIM acc. Tsui2Cleared 510(K)
- K190345VPC2Cleared 510(K)
- K161075Arrow Epidural Catheter Kit2Cleared 510(K)
- K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set2Cleared 510(K)
- K143581Arrow Epidural Catheter Kit2Cleared 510(K)
- K122690ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE2Cleared 510(K)
- K110053CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT2Cleared 510(K)
- K122027ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER2Cleared 510(K)
- K121525PERIFUSE CATHETER2Cleared 510(K)
- K121403CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET2Cleared 510(K)
- K103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER2Cleared 510(K)
- K113662FENESTRATED NERVE BLOCK NEEDLE2Cleared 510(K)
- K113188SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG2Cleared 510(K)
- K113059CONTIPLEX FX2Cleared 510(K)
- K111355ECHOBRIGHT2Cleared 510(K)
- K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,2Cleared 510(K)
- K093662ECHOBRIGHT2Cleared 510(K)
- K092657EPIFUSE CATHETER CONNECTOR, MODEL: 4909E2Cleared 510(K)
- K090995B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET2Cleared 510(K)
- K082183PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF2Cleared 510(K)
- K082164PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT2Cleared 510(K)
- K080804BUSSE PLASTIC LOR SYRINGE2Cleared 510(K)
- K073187PERIPHERAL NERVE BLOCK SUPPORT TRAY2Cleared 510(K)
- K063282CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET2Cleared 510(K)
- K062902PAJUNKS EPILONG SET PEDIATRIC2Cleared 510(K)
- K063018GLASS LOSS OF RESISTANCE SYRINGE2Cleared 510(K)
- K062900PAJUNKS STIMULONG TSUI-METHOD SET2Cleared 510(K)
- K061737LOSS OF RESISTANCE SYRINGE2Cleared 510(K)
- K060186POLYPLEX STIMULATING CATHETER SYSTEM2Cleared 510(K)
- K060311EPILONG KIT FOR ANESTHESIOLOGY2Cleared 510(K)
- K060563EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV2Cleared 510(K)
- K052954CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET2Cleared 510(K)
- K053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET2Cleared 510(K)
- K052946MPS ACACIA NERVE BLOCK NEEDLE2Cleared 510(K)
- K051171STINGRAY EPIDURAL CATHETER CONNECTOR2Cleared 510(K)
- K043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS2Cleared 510(K)
- K041158ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM2Cleared 510(K)
- K033018STIMULONG PLUS CATHETER SET MODEL, VARIOUS2Cleared 510(K)
- K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER2Cleared 510(K)
- K033952PERIFIX CATHETER CONNECTOR2Cleared 510(K)
- K031128B-SMART, MODEL B-012Cleared 510(K)
- K032144PERIFIX CATHETER CONNECTOR2Cleared 510(K)
- K022752PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-152Cleared 510(K)
- K030937STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK2Cleared 510(K)
- K014246AVID-NIT NERVE STIMULATION NEEDLES2Cleared 510(K)
- K021567STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-050002Cleared 510(K)
- K013041PLEXOLONG SETS2Cleared 510(K)
- K012584MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT2Cleared 510(K)
- K994059CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-072Cleared 510(K)
- K001940MICOR ANESTHESIA CONDUCTION KIT2Cleared 510(K)
- K00158719 GA PLASTIC REINFORCED EPIDURAL CATHETER2Cleared 510(K)
- K001129PROLONG, MODELS PL50, PL100, PL1502Cleared 510(K)
- K991719EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS2Cleared 510(K)
- K983125EPIDURAL CATHETER MODELS 1210/12002Cleared 510(K)
- K971233SOFT TIP EPIDURAL CATHETER KIT2Cleared 510(K)
- K962696PERIFIX PEDIATRIC EPIDURAL KIT2Cleared 510(K)
- K965017REGIONAL ANESTHESIA TRAYS2Cleared 510(K)
- K964783EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT2Cleared 510(K)
- K962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM2Cleared 510(K)
- K962821EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT2Cleared 510(K)
- K961075MEDCARE REGIONAL ANETHESIA KIT2Cleared 510(K)
- K960619MORE-L INJECTOR KIT PLUS2Cleared 510(K)
- K954706KENDALL BLUNT TUOHY EPIDURAL NEEDLE2Cleared 510(K)
- K954953B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY2Cleared 510(K)
- K960100SPINAL SPECIALTIES NERVE BLOCK TRAY2Cleared 510(K)
- K954835HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET2Cleared 510(K)
- K951870MORELL INJECTOR2Cleared 510(K)
- K953790BD PERISAFE EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K953766KENDALL SAFETAP SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K953467B-D SPINAL ANESTHESIA TRAY SPINAL2Cleared 510(K)
- K944029CONTINUOUS EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K943319GERTIE MARX EPI-SPINAL TRAY2Cleared 510(K)
- K945484PIDURAL STEROID SYSTEM2Cleared 510(K)
- K950929SENSI-TOUCH EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K941153EPI-SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K945671CONTINUOUS EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K945497B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT2Cleared 510(K)
- K932614REGIONAL ANAESTHESIA TRAY2Cleared 510(K)
- K941343SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K941493KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT2Cleared 510(K)
- K935245EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K933721EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM2Cleared 510(K)
- K934526MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K931670CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS2Cleared 510(K)
- K933711E-SP COMBINED EPIDURAL-SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K932249DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA2Cleared 510(K)
- K930161ANAGO SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K924707VARIOUS ANESTHETIC KITS OR TRAYS2Cleared 510(K)
- K925014E-SP COMBINED EPI SPINAL MINISET2Cleared 510(K)
- K922162CURITY PLASTIC LOSS OF RESISTANCE SYRINGE2Cleared 510(K)
- K920615ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT2Cleared 510(K)
- K925902B-D LOSS OF RESISTANCE SYRINGE2Cleared 510(K)
- K912445MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT2Cleared 510(K)
- K912322MEGA SPINAL ANESTHESIA KIT2Cleared 510(K)
- K904440LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS2Cleared 510(K)
- K903761CURITY SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K904101COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K903887CURITY NERVE BLOCK TRAY2Cleared 510(K)
- K902647CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY2Cleared 510(K)
- K902312COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K896799PARACERVICAL/PUDENDAL TRAYS2Cleared 510(K)
- K895955LOPER CELIAC PLEXUS BLOCK CATHETER KIT2Cleared 510(K)
- K895476OPTION EPIDURAL CATHETERS2Cleared 510(K)
- K896392MEDTRONIC EPIDURAL CATHETER KIT MODEL 87172Cleared 510(K)
- K894725MEDIZIV EPIDURAL SYSTEMS2Cleared 510(K)
- K895192SPINOCAN(R) CONTINUOUS SPINAL TRAY2Cleared 510(K)
- K892660HIBERNATION KIT2Cleared 510(K)
- K893938CONTINUOUS EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K891281INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.2Cleared 510(K)
- K890731MEDSURG EPIDURAL TRAY/19 GA/BUL TIP/17GA TUO 10022Cleared 510(K)
- K890733MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 10122Cleared 510(K)
- K890732MEDSURG EPIDURAL TRAY/BULLET TIP/17 GA TUOHY 1002E2Cleared 510(K)
- K890730MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 10002Cleared 510(K)
- K885278EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K884552CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER2Cleared 510(K)
- K885277SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K885238CURITY CONTINUOUS SPINAL ANESTHESIA TRAY2Cleared 510(K)
- K883314PMT 3721-1 EPIDURAL KIT2Cleared 510(K)
- K882394MEDTRONIC EPIDURAL CATHETER KIT MODEL 87162Cleared 510(K)
- K881429YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.2Cleared 510(K)
- K880970AXILLARY BLOCK NEEDLE2Cleared 510(K)
- K874674AIK-100 ANESTHESIA INDUCTION KIT/TRAY2Cleared 510(K)
- K880181REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K874105BRACHIAL PLEXUS CATHETER - BP-012002Cleared 510(K)
- K873943CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS2Cleared 510(K)
- K871066CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K860833EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K854518EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K851134REGIONAL ANESTHESIA TRAYS2Cleared 510(K)
- K851479VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 1932Cleared 510(K)
- K844982VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY2Cleared 510(K)
- K842095EPIDURAL TRAYS2Cleared 510(K)
- K840179CONTINUOUS EPIDURAL ANESTHES. TRAY2Cleared 510(K)
- K840287BRACHIAL PLEXUS ANESTHESIA TRAY2Cleared 510(K)
- K832778EPIDURAL SYRINGE2Cleared 510(K)
- K822691VYGON EPIDURAL ANAESTHESIA TRAY2Cleared 510(K)
- K813186PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO2Cleared 510(K)
- K802290REGIONAL INTRAVENOUS ANESTHESIA KIT2Cleared 510(K)
- K801912ARROW POSITIVE PLACEMENT CON/EPIDURAL AN2Cleared 510(K)
- K801724CURITY PARACERVICAL/PUDENDAL BLOCK ANES2Cleared 510(K)
- K781469POSITIVE PLACEMENT ANETHESIA KIT2Cleared 510(K)
- K782069TRAY, AUXILLARY BLOCK2Cleared 510(K)
- K781052CONTINUOUS EPIDURAL ANESTHESIA TRAY2Cleared 510(K)
- K780120ANESTHESIA TRAY, CAUDAL2Cleared 510(K)
- K770571TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS2Cleared 510(K)
- K770461ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.2Cleared 510(K)
- K770356ANESTHESIA KIT, EPIDURAL, SINGLE SHOT2Cleared 510(K)
- K770096EPIDURAL BLOCK PROCEDURE PACK2Cleared 510(K)
- K761162BRACHIAL PLEXUS BLOCK ANESTHESIA KIT2Cleared 510(K)
- K760352CIRCUIT, INTENSIVE CARE VENTILATOR2Cleared 510(K)
- K760343TRAY, CURITY CONTINUOUS EPIDURAL2Cleared 510(K)
- K760249TRAY, STERILE DISPOSABLE ARTHROGRAM2Cleared 510(K)
- CBFChamber, Hyperbaric2Product Code
- CBGSpreader, Cuff1Product Code
- CBHDevice, Fixation, Tracheal Tube1Product Code
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2Product Code
- CBKVentilator, Continuous, Facility Use2Product Code
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- MODAccessory To Continuous Ventilator (Respirator)2Product Code
- CCOBed, Rocking, Breathing Assist2Product Code
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1Product Code
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia2Product Code
- CCWLaryngoscope, Rigid1Product Code
- EPEBrush, Cleaning, Tracheal Tube1Product Code
- FNCTent, Pediatric Aerosol2Product Code
- FOGHood, Oxygen, Infant1Product Code
- JAYSupport, Breathing Tube1Product Code
- JOHTube Tracheostomy And Tube Cuff2Product Code
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)1Product Code
- KGBMask, Oxygen, Non-Rebreathing1Product Code
- KHAMask, Scavenging1Product Code
- LNZChanger, Tube, Endotracheal2Product Code
- MIANeedle, Spinal, Short Term2Product Code
- MNSVentilator, Continuous, Non-Life-Supporting2Product Code
- MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use2Product Code
- MRNApparatus, Nitric Oxide Delivery2Product Code
- MROApparatus, Nitric Oxide, Backup Delivery2Product Code
- MZTDevice, Heimlich Maneuver Assist2Product Code
- NFBConserver, Oxygen2Product Code
- NHJDevice, Positive Pressure Breathing, Intermittent2Product Code
- NHKResuscitator, Manual, Non Self-Inflating2Product Code
- NMATube, Tracheal, Reprocessed2Product Code
- NMCMask, Ventilator, Non-Continuous, Reprocessed2Product Code
- NMRNeedle, Spinal, Short Term, Reprocessed2Product Code
- NNHNeedle, Conduction, Anesthesia, Reprocessed2Product Code
- NOUContinuous, Ventilator, Home Use2Product Code
- NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use2Product Code
- NVOSpacer, Direct Patient Interface2Product Code
- NVPHolding Chambers, Direct Patient Interface2Product Code
- NXATracheotomy Care Kit2Product Code
- OBNHumidifier, Respiratory, Mask (Direct Patient Interface)2Product Code
- OFQAnesthesia Kit2Product Code
- OFTSpinal Epidural Anesthesia Kit2Product Code
- OFUSpinal Anesthesia Kit2Product Code
- OFVRegional Anesthesia Kit2Product Code
- OGABrachial Plexus Anesthesia Kit2Product Code
- OGBCaudal Anesthesia Kit2Product Code
- OGCContinuous Brachial Plexus Block Tray2Product Code
- OGDCustom Anesthesia Tray2Product Code
- OGEEpidural Anesthesia Kit2Product Code
- OGFGlossopharyngeal Anesthesia Kit2Product Code
- OGGHumidifier Nebulizer Kit2Product Code
- OGHLaryngoscope Kit1Product Code
- OGINasal Endotracheal Tube Holder Kit1Product Code
- OGJNerve Block Tray2Product Code
- OGLOxygen Administration Kit2Product Code
- OLFMedevac Use Oxygen Generator2Product Code
- ONZMechanical Ventilator2Product Code
- OQUAirway Monitoring System2Product Code
- PHSOral Airway Assist1Product Code
- PMBExternal Airway2Product Code
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2Product Code
- QBYPositive Airway Pressure System2Product Code
- QCXRetrograde Intubation Set2Product Code
- OZRIntraoral Pressure Gradient Device2Product Code
- QFBIsocapnic Ventilation Device2Product Code
- 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
B-SMART, MODEL B-01
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K031128
- 510(k) Type
- Traditional
- Applicant
- MACOSTA MEDICAL USA, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/15/2004
- Days to Decision
- 281 days
- Submission Type
- Statement