FDA 510(k)

藍色400；藍色400 S

K 號：K240215 · 2024-06-28

決定日期2024-06-28

產品代碼QFX

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

BLUE 400; BLUE 400 S is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2024-06-28 under 510(k) number K240215. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BLUE 400; BLUE 400 S?

BLUE 400; BLUE 400 S is a medical device that received FDA 510(k) clearance on 2024-06-28. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K240215.

When did BLUE 400; BLUE 400 S receive FDA 510(k) clearance?

BLUE 400; BLUE 400 S received FDA 510(k) clearance on 2024-06-28, under 510(k) number K240215.

Who is the listed applicant for BLUE 400; BLUE 400 S?

FDA 510(k) 記錄將 Carl Zeiss Meditec, AG 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BLUE 400; BLUE 400 S?

The FDA product code for BLUE 400; BLUE 400 S is QFX.