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
- 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
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- 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
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- UnknownReview Panel
Monitor, Air Embolism, Ultrasonic
- Page Type
- Product Code
- Regulation Medical Specialty
- Anesthesiology
- Review Panel
- Anesthesiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 868.2025
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 868.2025 Ultrasonic air embolism monitor
§ 868.2025 Ultrasonic air embolism monitor.
(a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.
(b) Classification. Class II (performance standards).