FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Huvitz Imaging System
K Number: K191615
·
Decision Jul 18, 2019
Classifications
1
FEI Numbers
33
Registration Numbers
34
Same Product Code
50
Applicant Total
3
Review Days
30
Basic Information
- Device Name
- Huvitz Imaging System
- K Number
- K191615
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huvitz Co., Ltd.
- Date Received
- June 18, 2019
- Decision Date
- July 18, 2019
- Product Code
- NFJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
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