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
- BXHGauge, Gas Pressure, Cylinder/Pipeline1Product Code
- BXMStimulator, Nerve, Ac-Powered2Product Code
- BXNStimulator, Nerve, Battery-Powered2Product Code
- K213049STIMPOD NMS450 Nerve Stimulator2Cleared 510(K)
- K162086MultiStim ECO2Cleared 510(K)
- K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator2Cleared 510(K)
- K143095MiniStim MS-IVB Peripheral Nerve Stimulator2Cleared 510(K)
- K140853STIMPOD ST2-3010 NERVE STIMULATOR2Cleared 510(K)
- K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN2Cleared 510(K)
- K111985MYOGUIDE SYSTEM MODEL 80082Cleared 510(K)
- K110118STIMTRODE SINGLE USE NERVE STIMULATOR2Cleared 510(K)
- K102084STIMPOD NMS450 NERVE STIMULATOR2Cleared 510(K)
- K093591STIMPOD MODEL NMS-400 NERVE STIMULATOR2Cleared 510(K)
- K091155ASCEND2Cleared 510(K)
- K072092XPOD/XMAP NERVE STIMULATOR2Cleared 510(K)
- K070134MODIFICATION TO STIMUPLEX HNS-12, MODEL 48920982Cleared 510(K)
- K062478CLAVIS2Cleared 510(K)
- K061983STIMUPLEX PEN2Cleared 510(K)
- K061172PAJUNK MULTISTIM SENSOR NERVE STIMULATORS2Cleared 510(K)
- K052313STIMUPLEX HNS-12, MODEL 48920982Cleared 510(K)
- K021033STIMUPLEX-DIG-RC NERVE STIMULATOR2Cleared 510(K)
- K011308MULTISTIM2Cleared 510(K)
- K990323TE ME NA POLYSTIM NERVE STIMILATOR2Cleared 510(K)
- K003983STIMUPLEX HNS-112Cleared 510(K)
- K954525SENSI-TOUCH EPIDURAL ANESTHESIA FILTER2Cleared 510(K)
- K914164VITALMAX 840 SERIES2Cleared 510(K)
- K913184MS-III MINISTIM2Cleared 510(K)
- K905092NEUROMUSCULAR TRANSMISSION MONITOR2Cleared 510(K)
- K904025MYOTRACK, MODEL HH 5152Cleared 510(K)
- K896368MODIFIED AXOSTIM2Cleared 510(K)
- K892396MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR2Cleared 510(K)
- K894786BIO-INDUSTRY STIM POCHE(R)2Cleared 510(K)
- K893485ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR2Cleared 510(K)
- K890746MYOTEST DBS NERVE STIMULATOR2Cleared 510(K)
- K883807AXOSTIM2Cleared 510(K)
- K883868MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM2Cleared 510(K)
- K881842TRACER2Cleared 510(K)
- K882438CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS2522Cleared 510(K)
- K870619ACCELOGRAPH2Cleared 510(K)
- K870338MODEL MS-II MINISTIM2Cleared 510(K)
- K864830TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK2Cleared 510(K)
- K864829MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT2Cleared 510(K)
- K862149MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR2Cleared 510(K)
- K861935MODEL 100 NERVE STIMULATOR2Cleared 510(K)
- K860186MYOTEST - NERVE STIMULATOR2Cleared 510(K)
- K860187MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING2Cleared 510(K)
- K860126STIMUPLEX, NERVE STIMULATOR2Cleared 510(K)
- K853422THE GRIPPER2Cleared 510(K)
- K853476T4 MONITOR STIMULATOR COMPUTER2Cleared 510(K)
- K853477NERVE FINDER2Cleared 510(K)
- K853849MEDAR APM FORCE TRANSDUCER2Cleared 510(K)
- K852962PERIPHERAL NERVE STIMULATOR MODEL A4002Cleared 510(K)
- K843175NERVE STIMULATOR Q102Cleared 510(K)
- K830058MYOGRAPH 20002Cleared 510(K)
- K823583MYOTEST NERVE STIMULATOR2Cleared 510(K)
- K822139STIMPEN2Cleared 510(K)
- K822157PERIPHERAL NERVE STIMULATOR, MODEL A-2002Cleared 510(K)
- K822137DIGISTIM II2Cleared 510(K)
- K822138NEUROSTIM II2Cleared 510(K)
- K811614NERVE STIMULATOR MODEL AA 10502Cleared 510(K)
- K791442BARD BIOMEDICAL NERVE LOCATOR2Cleared 510(K)
- K791047NERVE STIMULATOR, DIGITAL PERIPHERAL2Cleared 510(K)
- K790123STIMULATOR, BATTERY POWERED2Cleared 510(K)
- K771765MYO-CHECK2Cleared 510(K)
- K771237NERVE STIMULATORS2Cleared 510(K)
- K760614PERIPHERAL NERVE STIMULATOR2Cleared 510(K)
- BXOTransducer, Gas Pressure1Product Code
- BXPTransducer, Gas Flow1Product Code
- BXXCalibrator, Pressure, Gas1Product Code
- BXYFlowmeter, Calibration, Gas1Product Code
- BYMTube, Thorpe, Uncompensated1Product Code
- BYRTransducer, Gas Pressure, Differential1Product Code
- BZQMonitor, Breathing Frequency2Product Code
- CANRegulator, Pressure, Gas Cylinder1Product Code
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)2Product Code
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1Product Code
- CBAMonitor, Air Embolism, Ultrasonic2Product Code
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge1Product Code
- ECXCylinder, Compressed Gas, And Valve1Product Code
- FLSMonitor, Apnea, Facility Use2Product Code
- JAXPneumotachometer2Product Code
- JEZMonitor, Lung Water Measurement3Product Code
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2Product Code
- KOIStimulator, Nerve, Peripheral, Electric2Product Code
- LKDMonitor, Carbon-Dioxide, Cutaneous2Product Code
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia2Product Code
- MNRVentilatory Effort Recorder2Product Code
- MRPAnalyzer, Nitric Oxide2Product Code
- MRQAnalyzer, Nitrogen Dioxide2Product Code
- NPFMonitor, Apnea, Home Use2Product Code
- PRKDevice Indicating An Exhalation Event2Product Code
- PUGAnalyzer, Nitrogen Dioxide, Exempt2Product Code
- PXEPressure Monitoring (Air/Gas) Kit1Product Code
- 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
ACCELOGRAPH
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K870619
- 510(k) Type
- Traditional
- Applicant
- BIOMETER INTL. A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/16/1987
- Days to Decision
- 32 days