FDA 510(k)

涼頻

K 號：K192940 · 2019-11-15

決定日期2019-11-15

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

CoolTone is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192940. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoolTone?

CoolTone is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K192940.

When did CoolTone receive FDA 510(k) clearance?

CoolTone received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192940.

Who is the listed applicant for CoolTone?

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

What is the FDA product code for CoolTone?

The FDA product code for CoolTone is NGX.

其他以 Zimmer Medizinsysteme GmbH 為申請人之記錄

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相關器械（代碼：NGX）

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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