Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Device Code: 141

Product Code(s): KLK

Device Classification Information

• Device Type ID: 141
• Device Name: Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
• Regulation Description: Cutaneous Oxygen (PcO2) Monitor.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• 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
• CFR Regulation Number: 868.2500 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KLK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 1-87 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

Total Product Life Cycle

• Device Type ID: 141
• Device: Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
• Product Code: KLK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Cutaneous Oxygen (PcO2) Monitor.
• CFR Regulation Number: 868.2500 [🔎]

TPLC Last Update: 2019-04-02 19:29:37