FDA 510(k) Applications for Medical Device Product Code "LIL"
(Monitor, Penile Tumescence)

FDA 510(k) Number Applicant Device Name Decision Date
K033126 BEHAVIORAL TECHNOLOGY, INC. MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM 10/29/2003
K991479 LABORIE MEDICAL TECH CORP. VISER PENILE TUMESCENCE MONITOR 07/07/1999
K052929 LIMESTONE TECHNOLOGIES INC. PREFTEST PROFESSIONAL SUITE 04/26/2006
K062042 PLETHORA SOLUTIONS PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) 09/06/2006
K061676 UROAN 21 RIGIDOMETER, MODEL DIR-4U 12/27/2006
K000194 UROAN XXI ELECTROMEDICINA DIGITAL INFLECTION RIGIDOMETER (DIR) 04/10/2000
K980627 UROMETRICS, INC. NEVA SYSTEM 04/07/1998


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