FDA 510(k)

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K 號：K183598 · 2019-11-15

決定日期2019-11-15

產品代碼MQC

決定相當於

器材摘要

KeyPrint KeySplint Soft is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Industries. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K183598. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the KeyPrint KeySplint Soft?

KeyPrint KeySplint Soft is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Keystone Industries. The 510(k) number is K183598.

When did KeyPrint KeySplint Soft receive FDA 510(k) clearance?

KeyPrint KeySplint Soft received FDA 510(k) clearance on 2019-11-15, under 510(k) number K183598.

Who is the listed applicant for KeyPrint KeySplint Soft?

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

What is the FDA product code for KeyPrint KeySplint Soft?

The FDA product code for KeyPrint KeySplint Soft is MQC.

其他以 Keystone Industries 為申請人之記錄

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相關器械（代碼：MQC）

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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官方來源

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