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U.S. Department of Health and Human Services

Product Classification

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Device thermometer, electronic, clinical
Regulation Description Clinical electronic thermometer.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFLL
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 880.2910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers
Third Party Review
Accredited Persons

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