FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TUMISTORE RECORDER 1311
K Number: K831252
·
Decision May 18, 1983
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
68
Review Days
30
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Basic Information
- Device Name
- TUMISTORE RECORDER 1311
- K Number
- K831252
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- April 18, 1983
- Decision Date
- May 18, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIL), ordered by most recent decision date.
RIGIDOMETER, MODEL DIR-4U
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PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
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PREFTEST PROFESSIONAL SUITE
FDA 510(k)
FDA Unclassified
·Unknown
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DIGITAL INFLECTION RIGIDOMETER (DIR)
FDA 510(k)
FDA Unclassified
·Unknown
VISER PENILE TUMESCENCE MONITOR
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Life-Tech Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001129 | PROLONG, MODELS PL50, PL100, PL150 | Jul 6, 2000 | Substantially Equivalent |
| K955031 | MAXISTIM | Dec 10, 1996 | Substantially Equivalent |
| K954505 | EZ STIM | Dec 10, 1996 | Substantially Equivalent |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Nov 30, 1995 | Substantially Equivalent |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Oct 17, 1995 | Substantially Equivalent |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 5, 1995 | Substantially Equivalent |
| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |