Tumisensor 1524
FDA 510(k) K831251 · Life-Tech Intl., Inc.
510(k) numberK831251
Submission
- Device name
- Tumisensor 1524
- Applicant
- Life-Tech Intl., Inc.
Mchenry, IL, US - Received
- April 18, 1983
- Decision date
- June 3, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIL – Monitor, Penile Tumescence
- Device class
- Unclassified
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| K052929 | Preftest Professional SuiteLIL · Traditional | Limestone Technologies, Inc. | 04/26/2006SE |
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| 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 |
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| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
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Questions and answers
When was Tumisensor 1524 cleared by the FDA?
Tumisensor 1524 (K831251) received a 510(k) decision of Substantially Equivalent on June 3, 1983, 46 days after the submission was received.
What is the product code of K831251?
The FDA product code is LIL – Monitor, Penile Tumescence, a Unclassified device.