FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CAT-600 PENILE PLETHYSMOGRAPH
K Number: K936115
·
Decision Jan 10, 1995
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
7
Review Days
690
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Basic Information
- Device Name
- CAT-600 PENILE PLETHYSMOGRAPH
- K Number
- K936115
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Farrall Instruments, Inc.
- Date Received
- February 19, 1993
- Decision Date
- January 10, 1995
- Product Code
- LIL
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LIL | Monitor, Penile Tumescence | FDA unclassified | Unknown |
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VISER PENILE TUMESCENCE MONITOR
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·Unknown
Other Clearances by Farrall Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940128 | CAT-400UL PENILE PLETHYSMOGRAPH | Jan 10, 1995 | Substantially Equivalent |
| K821723 | BI-4520 DUAL IMPEDOMETER | Sep 15, 1982 | Substantially Equivalent |
| K821664 | PP-100, PERSONAL PERINEOMETER | Jul 13, 1982 | Substantially Equivalent |
| K792305 | A SLEEP ASSESSMENT DEVICE | Dec 20, 1979 | Substantially Equivalent |
| K781634 | VISUALAX | Oct 3, 1978 | Substantially Equivalent |
| K760166 | STIMULATOR, SONIC CONTROL (AS-1) | Jul 20, 1976 | Substantially Equivalent |