FDA 510(k)

冷凍劑H或類似

K 號：K161337 · 2016-07-12

決定日期2016-07-12

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

CryoDose H or Similar is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K161337. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CryoDose H or Similar?

CryoDose H or Similar is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Nuance Medical, LLC. The 510(k) number is K161337.

When did CryoDose H or Similar receive FDA 510(k) clearance?

CryoDose H or Similar received FDA 510(k) clearance on 2016-07-12, under 510(k) number K161337.

Who is the listed applicant for CryoDose H or Similar?

The FDA 510(k) record lists Nuance Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryoDose H or Similar?

The FDA product code for CryoDose H or Similar is GEH.

其他以 Nuance Medical, LLC 為申請人之記錄

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。

K232674PainFreeze II K210310CryoDose V 50/50, 175ml 罐裝組合包，CryoDose V 50/50, 236ml 罐裝組合包 K172203CryoDose TA OTC，霧狀噴霧，CryoDose TA OTC，流動噴霧 K162218Pain Freeze™，中流量噴霧，型號 #2101；Pain Freeze™，霧狀噴霧，型號 #2102

相關器械（代碼：GEH）

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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