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FDA 510(k)

數位診斷 C50

K 號:K163410 · 2017-01-04

決定日期2017-01-04
產品代碼KPR
諮詢委員會RA
決定相當於

器材摘要

DigitalDiagnost C50 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K163410. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DigitalDiagnost C50?

DigitalDiagnost C50 is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K163410.

When did DigitalDiagnost C50 receive FDA 510(k) clearance?

DigitalDiagnost C50 received FDA 510(k) clearance on 2017-01-04, under 510(k) number K163410.

Who is the listed applicant for DigitalDiagnost C50?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DigitalDiagnost C50?

The FDA product code for DigitalDiagnost C50 is KPR.

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其他以 Philips Healthcare (Suzhou) Co., Ltd. 為申請人之記錄

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相關器械(代碼:KPR)

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