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FDA 510(k)

EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control

K 號：K151978 · 2016-07-15

申請人Edan Instruments, Inc.
決定日期2016-07-15
產品代碼CHL
諮詢委員會CH
決定Substantially Equivalent

器材摘要

EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K151978. 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 EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control?

EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K151978.

When did EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control receive FDA 510(k) clearance?

EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control received FDA 510(k) clearance on 2016-07-15, under 510(k) number K151978.

Who is the listed applicant for EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control?

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

What is the FDA product code for EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control?

The FDA product code for EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control is CHL.

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官方來源

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