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U.S. Department of Health and Human Services

Product Classification

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Device incubator, neonatal
Regulation Description Neonatal incubator.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFMZ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Neonatal and Neonatal Transport Incubators - Premarket Notifications; Final
Third Party Review
Accredited Persons

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