Digital Inflection Rigidometer (Dir)
FDA 510(k) K000194 · Uroan Xxi Electromedicina
510(k) numberK000194
Submission
- Device name
- Digital Inflection Rigidometer (Dir)
- Applicant
- Uroan Xxi Electromedicina
Baleares, ES - Received
- January 21, 2000
- Decision date
- April 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIL – Monitor, Penile Tumescence
- Device class
- Unclassified
Other 510(k)s with product code LIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061676 | Rigidometer, Model DIR-4ULIL · Traditional | Uroan 21 | 12/27/2006SE |
| K062042 | Plethora Solutions Sexual Assessment Monitor (Sam)LIL · Traditional | Plethora Solutions | 09/06/2006SE |
| K052929 | Preftest Professional SuiteLIL · Traditional | Limestone Technologies, Inc. | 04/26/2006SE |
| K033126 | Monarch 21 Penile Plethysmograph SystemLIL · Special | Behavioral Technology, Inc. | 10/29/2003SE |
| K991479 | Viser Penile Tumescence MonitorLIL · Traditional | Laborie Medical Tech Corp. | 07/07/1999SE |
| K980627 | Neva SystemLIL · Traditional | Urometrics, Inc. | 04/07/1998SE |
| K940128 | CAT-400UL Penile PlethysmographLIL · Traditional | Farrall Instruments, Inc. | 01/10/1995SE |
| K936115 | CAT-600 Penile PlethysmographLIL · Traditional | Farrall Instruments, Inc. | 01/10/1995SE |
| K941781 | Rigiscan Plus Rigidity Assessment SystemLIL · Traditional | Dacomed Corp. | 08/25/1994SE |
| K925931 | RT2 Rigidity and Tumescence TestLIL · Traditional | Compass Medical Technologies, Inc. | 12/21/1992SE |
Questions and answers
When was Digital Inflection Rigidometer (Dir) cleared by the FDA?
Digital Inflection Rigidometer (Dir) (K000194) received a 510(k) decision of Substantially Equivalent on April 10, 2000, 80 days after the submission was received.
What is the product code of K000194?
The FDA product code is LIL – Monitor, Penile Tumescence, a Unclassified device.