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U.S. Department of Health and Human Services

Product Classification

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Device monitor, air embolism, ultrasonic
Regulation Description Ultrasonic air embolism monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBA
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.2025
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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