FDA 510(k)

フローラスアクセサリー（YELLOW 560およびINFRARED 800、FLOW 800オプション付き）

K番号: K231075 · 2023-06-20

決定日2023-06-20

製品コードIZI

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K231075. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)?

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K231075.

When did Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) receive FDA 510(k) clearance?

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) received FDA 510(k) clearance on 2023-06-20, under 510(k) number K231075.

Who is the listed applicant for Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)?

The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)?

The FDA product code for Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is IZI.

申請者としてCarl Zeiss Meditec, Inc.を記載するその他の記録

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