CAT-600 Penile Plethysmograph
FDA 510(k) K936115 · Farrall Instruments, Inc.
510(k) numberK936115
Submission
- Device name
- CAT-600 Penile Plethysmograph
- Applicant
- Farrall Instruments, Inc.
Grand Island, NE, US - Received
- February 19, 1993
- Decision date
- January 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K000194 | Digital Inflection Rigidometer (Dir)LIL · Traditional | Uroan Xxi Electromedicina | 04/10/2000SE |
| 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 |
| 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 |
More from Compass Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940128 | CAT-400UL Penile PlethysmographLIL · Traditional | 01/10/1995SE |
| K821723 | BI-4520 Dual Impedometer · Traditional | 09/15/1982SE |
| K821664 | PP-100, Personal PerineometerHIR · Traditional | 07/13/1982SE |
| K792305 | A Sleep Assessment DeviceLEL · Traditional | 12/20/1979SE |
| K781634 | VisualaxHCC · Traditional | 10/03/1978SE |
| K760166 | Stimulator, Sonic Control (AS-1)HCB · Traditional | 07/20/1976SE |
Questions and answers
When was CAT-600 Penile Plethysmograph cleared by the FDA?
CAT-600 Penile Plethysmograph (K936115) received a 510(k) decision of Substantially Equivalent on January 10, 1995, 690 days after the submission was received.
What is the product code of K936115?
The FDA product code is LIL – Monitor, Penile Tumescence, a Unclassified device.