Algesimeter, Manual

Device Code: 36

Product Code(s): BXL

Device Classification Information

Device Type ID36
Device NameAlgesimeter, Manual
Regulation DescriptionManual Algesimeter.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(K) Exempt
CFR Regulation Number868.1030 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBXL
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID36
DeviceAlgesimeter, Manual
Product CodeBXL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Algesimeter.
CFR Regulation Number868.1030 [🔎]
TPLC Last Update: 2019-04-02 19:27:13

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