KYA — System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) Class I

FDA Device Classification

FDA product code KYA covers "System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)", a Class I medical device regulated under 21 CFR 884.2982. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KYA
Device Class
Class I
Regulation Number
884.2982
Submission Type
Review Panel
RA
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K900404PromedexVARICOSCREEN(TM)Dec 7, 1990
K832989Bcsi LaboratoriesBREAST THERMAL ACTIVITY INDICATORJan 17, 1984
K823245American Thermometer CompanyTHERMAX; THERMAX SYSTEMNov 16, 1982
K821524John D. Reid B.A., D.CCHIROPRATIC INFRA-RED CRYSTAL PAKSep 8, 1982
K821049American Thermometer CompanyPARATHERMApr 29, 1982