FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
PEERSCOPE SYSTEM
K Number: K130718
·
Decision Apr 16, 2013
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
111
Applicant Total
1
Review Days
29
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Basic Information
- Device Name
- PEERSCOPE SYSTEM
- K Number
- K130718
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peermedical , Ltd.
- Date Received
- March 18, 2013
- Decision Date
- April 16, 2013
- 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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