FDA 510(k)

Gebauer的疼痛輕鬆局部麻醉皮膚冷凍劑（霧狀噴劑和中等噴劑）

K 號：K172028 · 2017-10-27

決定日期2017-10-27

產品代碼MLY

決定相當於

器材摘要

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is the device name listed in this FDA 510(k) record. The listed applicant is Gebauer Company. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K172028. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常見問題

What is the Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Gebauer Company. The 510(k) number is K172028.

When did Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) receive FDA 510(k) clearance?

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) received FDA 510(k) clearance on 2017-10-27, under 510(k) number K172028.

Who is the listed applicant for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

FDA 510(k) 記錄將 Gebauer Company 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

The FDA product code for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is MLY.

其他以 Gebauer Company 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。

K260870Gebauer's 疼痛輕鬆局部麻醉皮膚冷凍劑（霧狀噴劑和中等噴劑）K190161乙基氯中間噴射，乙基氯精準點噴，乙基氯霧，乙基氯Accustream 360* 中噴，乙基氯Accustream 360* 精準噴

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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