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
- 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
- K220530Tetragraph Neuromuscular Transmission Monitor2Cleared 510(K)
- K220976Life Scope PT BSM-1700 Series Bedside Monitor2Cleared 510(K)
- K212434Neuromuscular Transmission Monitor TOF3D2Cleared 510(K)
- K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM2Cleared 510(K)
- K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series2Cleared 510(K)
- K192958TwitchView System2Cleared 510(K)
- K190795Tetragraph Neuromuscular Transmission Monitor2Cleared 510(K)
- K172690ToFscan2Cleared 510(K)
- K172843TwitchView System2Cleared 510(K)
- K162048EZstim*III Peripheral Nerve Stimulator/Nerve Locator2Cleared 510(K)
- K051635DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES2Cleared 510(K)
- K042003INFINITY TRIDENT NMT POD2Cleared 510(K)
- K023342NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG2Cleared 510(K)
- K002889PNS MAGNETIC STIMULATOR SYSTEM2Cleared 510(K)
- K992598TOF-WATCH SX2Cleared 510(K)
- K992596TOF-WATCH S2Cleared 510(K)
- K972698TOF-WATCH2Cleared 510(K)
- K955026AS/3 NMT MODULE2Cleared 510(K)
- K955031MAXISTIM2Cleared 510(K)
- K954505EZ STIM2Cleared 510(K)
- K953205CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)2Cleared 510(K)
- K925159TOF-GUARD TRANSMISSION MONITOR2Cleared 510(K)
- K924234CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS2722Cleared 510(K)
- K861091EASISTIM2Cleared 510(K)
- K840108NEUROMUSCULAR TRANSMISSION MONITOR2Cleared 510(K)
- 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
AS/3 NMT MODULE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K955026
- 510(k) Type
- Traditional
- Applicant
- DATEX MEDICAL INSTRUMENTATION, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/28/1997
- Days to Decision
- 543 days
- Submission Type
- Summary