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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 Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(k)
Regulation Number 868.2025
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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