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U.S. Department of Health and Human Services

Product Classification

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Device attachment, intermitant mandatory ventilation (imv)
Regulation Description Intermittent mandatory ventilation attachment.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBO
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 868.5955
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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