FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKOUT Software
K Number: K213686
·
Decision Aug 12, 2022
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
19
Applicant Total
4
Review Days
263
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Basic Information
- Device Name
- SKOUT Software
- K Number
- K213686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iterative Scopes, Inc.
- Date Received
- November 22, 2021
- Decision Date
- August 12, 2022
- Product Code
- QNP
- 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 |
|---|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | FDA class 2 | Gastroenterology, Urology |
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