FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Retina Workplace
K Number: K182318
·
Decision Oct 24, 2018
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
29
Review Days
58
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Basic Information
- Device Name
- Retina Workplace
- K Number
- K182318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, Inc.
- Date Received
- August 27, 2018
- Decision Date
- October 24, 2018
- 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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