FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K Number: K231075
·
Decision Jun 20, 2023
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
195
Applicant Total
4
Review Days
67
Basic Information
- Device Name
- Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- K Number
- K231075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec Inc
- Date Received
- April 14, 2023
- Decision Date
- June 20, 2023
- Product Code
- IZI
- Advisory Committee
- Radiology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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