FDA 510(k)

CryoDose TA OTC，霧狀噴霧，CryoDose TA OTC，流動噴霧

K 號：K172203 · 2017-10-18

決定日期2017-10-18

產品代碼MLY

決定相當於

器材摘要

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray 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 2017-10-18 under 510(k) number K172203. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常見問題

What is the CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Nuance Medical, LLC. The 510(k) number is K172203.

When did CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray receive FDA 510(k) clearance?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172203.

Who is the listed applicant for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

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 TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

The FDA product code for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is MLY.

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 K162218Pain Freeze™，中流量噴霧，型號 #2101；Pain Freeze™，霧狀噴霧，型號 #2102 K161337冷凍劑H或類似

相關器械（代碼：MLY）

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。

K261684冷凍噴霧機 TACryosurgery, Inc.K260870Gebauer's 疼痛輕鬆局部麻醉皮膚冷凍劑（霧狀噴劑和中等噴劑）Gebauer Company K243654牙科注射器Vapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLC K203661CRYO 北極，CRYO 企鵝Cryoscience North America, Inc.K202782數 Vapocoolant623 Medical, LLC

官方來源

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