FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
EyeSuite Imaging
K Number: K142423
·
Decision Sep 10, 2014
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
4
Review Days
13
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Basic Information
- Device Name
- EyeSuite Imaging
- K Number
- K142423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haag-Streit AG
- Date Received
- August 28, 2014
- Decision Date
- September 10, 2014
- Product Code
- NFJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- OP
- Third Party
- Y
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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