510(k) K033126
- Device
- MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
- Applicant
- BEHAVIORAL TECHNOLOGY, INC.
- 510(k) number
- K033126
- Product code
- LIL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-29
- Date received
- 2003-09-30
- Regulation
- 510(k) Premarket Notification
- Classification name
- Monitor, Penile Tumescence
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Gastroenterology/Urology
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN E OLSEN
- Address
- 24 M St., #1 Salt Lake City UT US 84103 84103
FDA Registration Numbers#
- 3011027014
- 2183673
Source Documents#
Other 510(k) Records For Product Code LIL #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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