FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINARY DRAINAGE MONITORING SYSTEM
K Number: K780134
·
Decision Feb 2, 1978
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
9
Applicant Total
49
Review Days
9
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Basic Information
- Device Name
- URINARY DRAINAGE MONITORING SYSTEM
- K Number
- K780134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Devices, Inc.
- Date Received
- January 24, 1978
- Decision Date
- February 2, 1978
- Product Code
- FCN
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCN), ordered by most recent decision date.
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BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
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DOUBLE CLOSED URINARY DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
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| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
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