FDA 510(k)

GEM Premier 7000 配合 IQM3

K 號：K223608 · 2023-08-10

決定日期2023-08-10

產品代碼CHL

諮詢委員會CH

決定相當於

器材摘要

GEM Premier 7000 with IQM3 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory Company. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K223608. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GEM Premier 7000 with IQM3?

GEM Premier 7000 with IQM3 is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Instrumentation Laboratory Company. The 510(k) number is K223608.

When did GEM Premier 7000 with IQM3 receive FDA 510(k) clearance?

GEM Premier 7000 with IQM3 received FDA 510(k) clearance on 2023-08-10, under 510(k) number K223608.

Who is the listed applicant for GEM Premier 7000 with IQM3?

The FDA 510(k) record lists Instrumentation Laboratory Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM Premier 7000 with IQM3?

The FDA product code for GEM Premier 7000 with IQM3 is CHL.

其他以 Instrumentation Laboratory Company 為申請人之記錄

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官方來源

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