FDA 510(k)

GLOW800

K 號：K181537 · 2018-09-07

決定日期2018-09-07

產品代碼IZI

諮詢委員會RA

決定相當於

器材摘要

GLOW800 is the device name listed in this FDA 510(k) record. The listed applicant is Leica Microsystems (Schweiz) AG. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181537. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GLOW800?

GLOW800 is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Leica Microsystems (Schweiz) AG. The 510(k) number is K181537.

When did GLOW800 receive FDA 510(k) clearance?

GLOW800 received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181537.

Who is the listed applicant for GLOW800?

The FDA 510(k) record lists Leica Microsystems (Schweiz) AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOW800?

The FDA product code for GLOW800 is IZI.

其他以 Leica Microsystems (Schweiz) AG 為申請人之記錄

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K170239萊卡FL560

相關器械（代碼：IZI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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