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
K822099 BIOREM BIOREM 2000 08/27/1982
K833454 BIOREM BIOREM 3000 & 4000 02/21/1984
K830221 BROWNE MEDICAL, INC. BEDSIDE N.P.T. 9900 - PRINTER 9800 03/17/1983
K880903 C.R. BARD, INC. BARD (R) ESKA ERECTIOMETER 05/06/1988
K925931 COMPASS MEDICAL TECHNOLOGIES, INC. RT2 RIGIDITY AND TUMESCENCE TEST 12/21/1992
K841202 DACOMED CORP. DACOMED RIGISCAN SYSTEM 07/06/1984
K820615 DACOMED CORP. DACOMED SNAP-GAUGE 04/21/1982
K832121 DACOMED CORP. DACOMED SNAP-GAUGE 07/18/1983
K941781 DACOMED CORP. RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM 08/25/1994
K940128 FARRALL INSTRUMENTS, INC. CAT-400UL PENILE PLETHYSMOGRAPH 01/10/1995
K936115 FARRALL INSTRUMENTS, INC. CAT-600 PENILE PLETHYSMOGRAPH 01/10/1995
K991479 LABORIE MEDICAL TECH CORP. VISER PENILE TUMESCENCE MONITOR 07/07/1999
K831251 LIFE-TECH INTL., INC. TUMISENSOR 1524 06/03/1983
K831252 LIFE-TECH INTL., INC. TUMISTORE RECORDER 1311 05/18/1983
K052929 LIMESTONE TECHNOLOGIES INC. PREFTEST PROFESSIONAL SUITE 04/26/2006
K841879 MEDICAL MONITORING SYSTEMS, INC. LFT - 212 07/26/1984
K810944 MEDICAL MONITORING SYSTEMS, INC. PENILE ERECTION MONITOR 04/23/1981
K851646 MULTICEPT, APS. VIBRECTOR 08/21/1985
K830158 OREXAS MEDICAL CORP. OREXAS POTENTEST 02/07/1983
K062042 PLETHORA SOLUTIONS PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) 09/06/2006
K875333 SURGITEK SURGITEK NPT MONITOR 04/13/1988
K870983 TEXAS MEDICAL ELECTRONICS CO. NOCTURNAL PENILE TUMESCENCE MONITOR 06/23/1987
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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