FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
K Number: K023633
·
Decision Dec 31, 2002
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
25
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- SOVIS OPTIQUE'S ENDOSCOPIC CABLE
- K Number
- K023633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sovis Optique
- Date Received
- October 29, 2002
- Decision Date
- December 31, 2002
- Product Code
- FFS
- 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 |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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