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U.S. Department of Health and Human Services

Product Classification

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Device monitor, apnea, facility use
Regulation Description Apnea monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeFLS
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 868.2377
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA
Third Party Review Not Third Party Eligible
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