FDA 510(k)

Klarity SRS ベースプレート、Klarity Promise ベースプレート

K番号: K220539 · 2022-11-01

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

決定日2022-11-01

製品コードIYE

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてKlarity Medical & Equipment (GZ) Co., Ltd.を記載するその他の記録

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