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U.S. Department of Health and Human Services

Product Classification

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Device changer, tube, endotracheal
Regulation Description Tracheal tube.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeLNZ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 868.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons