Analyzer, Rigidity

Device Code: 3688

Product Code(s): GZM

Device Classification Information

Device Type ID3688
Device NameAnalyzer, Rigidity
Regulation DescriptionRigidity Analyzer.
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 Number882.1020 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGZM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3688
DeviceAnalyzer, Rigidity
Product CodeGZM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRigidity Analyzer.
CFR Regulation Number882.1020 [🔎]
TPLC Last Update: 2019-04-02 20:34:32

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