Chair, Neurosurgical

Device Code: 3710

Product Code(s): HBN

Device Classification Information

Device Type ID3710
Device NameChair, Neurosurgical
Regulation DescriptionNeurosurgical Chair.
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 Number882.4125 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHBN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3710
DeviceChair, Neurosurgical
Product CodeHBN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNeurosurgical Chair.
CFR Regulation Number882.4125 [🔎]
Device Problems
Component Missing
7
Product Quality Problem
5
Device Operational Issue
4
Material Fragmentation
3
Device Issue
2
Device Misassembled During Manufacturing / Shipping
1
Incorrect Device Or Component Shipped
1
Material Frayed
1
Total Device Problems 24
TPLC Last Update: 2019-04-02 20:35:10

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