FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
COLONOSIGHT MODEL 510B
K Number: K032688
·
Decision Mar 5, 2004
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
111
Applicant Total
3
Review Days
189
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Basic Information
- Device Name
- COLONOSIGHT MODEL 510B
- K Number
- K032688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sightline Technologies , Ltd.
- Date Received
- August 29, 2003
- Decision Date
- March 5, 2004
- Product Code
- FDF
- 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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