FDA 510(k)

MyoSPECT, MyoSpect ES

K 號：K212004 · 2021-08-27

決定日期2021-08-27

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

MyoSPECT, MyoSpect ES is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K212004. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MyoSPECT, MyoSpect ES?

MyoSPECT, MyoSpect ES is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is GE Healthcare. The 510(k) number is K212004.

When did MyoSPECT, MyoSpect ES receive FDA 510(k) clearance?

MyoSPECT, MyoSpect ES received FDA 510(k) clearance on 2021-08-27, under 510(k) number K212004.

Who is the listed applicant for MyoSPECT, MyoSpect ES?

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

What is the FDA product code for MyoSPECT, MyoSpect ES?

The FDA product code for MyoSPECT, MyoSpect ES is KPS.

其他以 GE Healthcare 為申請人之記錄

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相關器械（代碼：KPS）

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。

官方來源

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