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U.S. Department of Health and Human Services

Product Classification

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Device monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia
Regulation Description Cutaneous oxygen (PcO2) monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeLPP
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) Exempt
Regulation Number 868.2500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Recognized Consensus Standard
Guidance Document
  • Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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