Product Classification

• Device: monitor, oxygen, cutaneous, for infant not under gas anesthesia
• Regulation Description: Cutaneous oxygen (PcO[bdi2]) monitor.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: KLK
• Submission Type: 510(k)
• Regulation Number: 868.2500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

Guidance Document

• Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.