System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use)

Device Code: 5262

Product Code(s): KYA

Device Classification Information

Device Type ID5262
Device NameSystem, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use)
Regulation DescriptionLiquid Crystal Thermographic System.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number884.2982 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKYA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5262
DeviceSystem, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use)
Product CodeKYA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLiquid Crystal Thermographic System.
CFR Regulation Number884.2982 [🔎]
TPLC Last Update: 2019-04-02 21:03:17

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