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FDA 510(k)

Pain Freeze™，中流量噴霧，型號 #2101；Pain Freeze™，霧狀噴霧，型號 #2102

K 號：K162218 · 2016-11-22

申請人Nuance Medical, LLC
決定日期2016-11-22
產品代碼MLY
決定相當於

器材摘要

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 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 2016-11-22 under 510(k) number K162218. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常見問題

What is the Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Nuance Medical, LLC. The 510(k) number is K162218.

When did Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 receive FDA 510(k) clearance?

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162218.

Who is the listed applicant for Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

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 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

The FDA product code for Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is MLY.

相關臨床試驗

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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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 IIK210310CryoDose 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 CompanyK243654牙科注射器Vapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLCK203661CRYO 北極，CRYO 企鵝Cryoscience North America, Inc.K202782數 Vapocoolant623 Medical, LLC

官方來源

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