Block, Test, Ultrasonic Scanner Calibration

Device Code: 3671

Product Code(s): GXX

Device Classification Information

Device Type ID3671
Device NameBlock, Test, Ultrasonic Scanner Calibration
Regulation DescriptionUltrasonic Scanner Calibration Test Block.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(K) Exempt
CFR Regulation Number882.1925 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGXX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3671
DeviceBlock, Test, Ultrasonic Scanner Calibration
Product CodeGXX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUltrasonic Scanner Calibration Test Block.
CFR Regulation Number882.1925 [🔎]
TPLC Last Update: 2019-04-02 20:34:09

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