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510(k) Data Aggregation
K Number
K020567Device Name
AKUPORT M1
Manufacturer
Date Cleared
2002-05-02
(71 days)
Product Code
Regulation Number
882.1540Why did this record match?
Applicant Name (Manufacturer) :
VIBRANT HEALTH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Galvanic Skin Response Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
Device Description
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K Number
K020565Device Name
EAV COMBI-2
Manufacturer
Date Cleared
2002-04-30
(69 days)
Product Code
Regulation Number
882.1540Why did this record match?
Applicant Name (Manufacturer) :
VIBRANT HEALTH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Galvanic Skin Response Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
Device Description
Not Found
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K Number
K020568Device Name
AKUPORT M-2
Manufacturer
Date Cleared
2002-04-30
(69 days)
Product Code
Regulation Number
882.1540Why did this record match?
Applicant Name (Manufacturer) :
VIBRANT HEALTH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Galvanic Skin Response Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
Device Description
Not Found
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