• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device oximeter, infrared, sporting, aviation
Regulation Description Oximeter.
Definition Solely for use with sporting and aviation activities.Intended to monitor heart rate during exercise.
Physical State sports watch that emits infrared
Technical Method Non-invasive infrared
Target Area Circulatory pulse
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOCH
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type Enforcement Discretion
Regulation Number 870.2700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-