FDA 510(k)

Klarity SRS 底板，Klarity Promise 底板

K 號：K220539 · 2022-11-01

申請人Klarity Medical & Equipment (GZ) Co., Ltd.

決定日期2022-11-01

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

Klarity SRS Baseplate, Klarity Promise Baseplate is the device name listed in this FDA 510(k) record. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. It received FDA 510(k) clearance on 2022-11-01 under 510(k) number K220539. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Klarity SRS Baseplate, Klarity Promise Baseplate?

Klarity SRS Baseplate, Klarity Promise Baseplate is a medical device that received FDA 510(k) clearance on 2022-11-01. The listed applicant is Klarity Medical & Equipment (GZ) Co., Ltd.. The 510(k) number is K220539.

When did Klarity SRS Baseplate, Klarity Promise Baseplate receive FDA 510(k) clearance?

Klarity SRS Baseplate, Klarity Promise Baseplate received FDA 510(k) clearance on 2022-11-01, under 510(k) number K220539.

Who is the listed applicant for Klarity SRS Baseplate, Klarity Promise Baseplate?

The FDA 510(k) record lists Klarity Medical & Equipment (GZ) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klarity SRS Baseplate, Klarity Promise Baseplate?

The FDA product code for Klarity SRS Baseplate, Klarity Promise Baseplate is IYE.

其他以 Klarity Medical & Equipment (GZ) Co., Ltd. 為申請人之記錄

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相關器械（代碼：IYE）

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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