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LIL — Monitor, Penile Tumescence Class U

FDA Device Classification

Classification Details

Product Code
LIL
Device Class
Class U
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K061676uroan 21RIGIDOMETER, MODEL DIR-4UDecember 27, 2006
K062042plethora solutionsPLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)September 6, 2006
K052929limestone technologiesPREFTEST PROFESSIONAL SUITEApril 26, 2006
K033126behavioral technologyMONARCH 21 PENILE PLETHYSMOGRAPH SYSTEMOctober 29, 2003
K000194uroan xxi electromedicinaDIGITAL INFLECTION RIGIDOMETER (DIR)April 10, 2000
K991479laborie medical techVISER PENILE TUMESCENCE MONITORJuly 7, 1999
K980627urometricsNEVA SYSTEMApril 7, 1998
K936115farrall instrumentsCAT-600 PENILE PLETHYSMOGRAPHJanuary 10, 1995
K940128farrall instrumentsCAT-400UL PENILE PLETHYSMOGRAPHJanuary 10, 1995
K941781dacomedRIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMAugust 25, 1994
K925931compass medical technologiesRT2 RIGIDITY AND TUMESCENCE TESTDecember 21, 1992
K880903c.r. bardBARD (R) ESKA ERECTIOMETERMay 6, 1988
K875333surgitekSURGITEK NPT MONITORApril 13, 1988
K870983texas medical electronicsNOCTURNAL PENILE TUMESCENCE MONITORJune 23, 1987
K851646multicept, apsVIBRECTORAugust 21, 1985
K841879medical monitoring systemsLFT - 212July 26, 1984
K841202dacomedDACOMED RIGISCAN SYSTEMJuly 6, 1984
K833454bioremBIOREM 3000 & 4000February 21, 1984
K832121dacomedDACOMED SNAP-GAUGEJuly 18, 1983
K831251life-tech intlTUMISENSOR 1524June 3, 1983