Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)— 510(k) K231075
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K231075 for Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option), Substantially Equivalent on 2023-06-20. Applicant: Carl Zeiss Meditec, Inc..
Clearance details
- Applicant
- Carl Zeiss Meditec, Inc.
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, CA, US
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.