Device, Galvanic Skin Response Measurement

Device Code: 3690

Product Code(s): GZO

Device Classification Information

Device Type ID3690
Device NameDevice, Galvanic Skin Response Measurement
Regulation DescriptionGalvanic Skin Response Measurement Device.
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 Number882.1540 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGZO
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 ID3690
DeviceDevice, Galvanic Skin Response Measurement
Product CodeGZO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGalvanic Skin Response Measurement Device.
CFR Regulation Number882.1540 [🔎]
Premarket Reviews
ManufacturerDecision
IMPETO MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
LD TECHNOLOGY LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MEDEIA, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Inappropriate Shock
 5
Installation-Related Problem
 2
Protective Measures Problem
 2
Total Device Problems 9
Recalls
Manufacturer Recall Class Date Posted
1
Hudson Scientific LLC
 II Aug-08-2018
2
ZYTO Technologies, Inc.
 II Jul-01-2016
TPLC Last Update: 2019-04-02 20:34:33
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.