Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
FDA 510(k) K231075 · Carl Zeiss Meditec, Inc.
510(k) numberK231075
Submission
- Device name
- Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- Applicant
- Carl Zeiss Meditec, Inc.
Dublin, CA, US - Received
- April 14, 2023
- Decision date
- June 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) cleared by the FDA?
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) received a 510(k) decision of Substantially Equivalent on June 20, 2023, 67 days after the submission was received.
What is the product code of K231075?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.