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