FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
URONIRS, MODEL 2000
K Number: K082701
·
Decision Dec 18, 2008
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
35
Applicant Total
1
Review Days
93
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Basic Information
- Device Name
- URONIRS, MODEL 2000
- K Number
- K082701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Urodynamix Technologies, Ltd.
- Date Received
- September 16, 2008
- Decision Date
- December 18, 2008
- Product Code
- FEN
- 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 |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | FDA class 2 | Gastroenterology, Urology |
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