Product code LIL
- Device name
- Monitor, Penile Tumescence
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061676 | RIGIDOMETER, MODEL DIR-4U | Uroan 21 | 2006-12-27 |
| K062042 | PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) | Plethora Solutions | 2006-09-06 |
| K052929 | PREFTEST PROFESSIONAL SUITE | Limestone Technologies, Inc. | 2006-04-26 |
| K033126 | MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM | Behavioral Technology, Inc. | 2003-10-29 |
| K000194 | DIGITAL INFLECTION RIGIDOMETER (DIR) | Uroan Xxi Electromedicina | 2000-04-10 |
| K991479 | VISER PENILE TUMESCENCE MONITOR | Laborie Medical Tech Corp. | 1999-07-07 |
| K980627 | NEVA SYSTEM | Urometrics, Inc. | 1998-04-07 |
| K940128 | CAT-400UL PENILE PLETHYSMOGRAPH | Farrall Instruments, Inc. | 1995-01-10 |
| K936115 | CAT-600 PENILE PLETHYSMOGRAPH | Farrall Instruments, Inc. | 1995-01-10 |
| K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | Dacomed Corp. | 1994-08-25 |
| K925931 | RT2 RIGIDITY AND TUMESCENCE TEST | Compass Medical Technologies, Inc. | 1992-12-21 |
| K880903 | BARD (R) ESKA ERECTIOMETER | C.R. Bard, Inc. | 1988-05-06 |
| K875333 | SURGITEK NPT MONITOR | Surgitek | 1988-04-13 |
| K870983 | NOCTURNAL PENILE TUMESCENCE MONITOR | Texas Medical Electronics Co. | 1987-06-23 |
| K851646 | VIBRECTOR | Multicept, Aps. | 1985-08-21 |
| K841879 | LFT - 212 | Medical Monitoring Systems, Inc. | 1984-07-26 |
| K841202 | DACOMED RIGISCAN SYSTEM | Dacomed Corp. | 1984-07-06 |
| K833454 | BIOREM 3000 & 4000 | Biorem | 1984-02-21 |
| K832121 | DACOMED SNAP-GAUGE | Dacomed Corp. | 1983-07-18 |
| K831251 | TUMISENSOR 1524 | Life-Tech Intl., Inc. | 1983-06-03 |
| K831252 | TUMISTORE RECORDER 1311 | Life-Tech Intl., Inc. | 1983-05-18 |
| K830221 | BEDSIDE N.P.T. 9900 - PRINTER 9800 | Browne Medical, Inc. | 1983-03-17 |
| K830158 | OREXAS POTENTEST | Orexas Medical Corp. | 1983-02-07 |
| K822099 | BIOREM 2000 | Biorem | 1982-08-27 |
| K820615 | DACOMED SNAP-GAUGE | Dacomed Corp. | 1982-04-21 |
| K810944 | PENILE ERECTION MONITOR | Medical Monitoring Systems, Inc. | 1981-04-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00363736000158 | Nix | Medtech Products Inc. | 2020-06-24 |
| 00363736109387 | Nix | Medtech Products Inc. | 2020-06-24 |
| 00363736110062 | Nix | Medtech Products Inc. | 2020-06-24 |
| 10854759007042 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 10854759007059 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007007 | RigiScan Plus | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007014 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007021 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007038 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007045 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007052 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007069 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007076 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007083 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007090 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |
| 00854759007106 | RigiScan | GOTOP MEDICAL INC | 2017-11-01 |