FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URODEC 500
K Number: K890284
·
Decision May 30, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
57
Review Days
131
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Basic Information
- Device Name
- URODEC 500
- K Number
- K890284
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Ferguson Medical
- Date Received
- January 19, 1989
- Decision Date
- May 30, 1989
- Product Code
- FES
- 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 |
|---|---|---|---|
| FES | Recorder, External, Pressure, Amplifier & Transducer | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FES), ordered by most recent decision date.
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