FDA 510(k)

返回 3 颜色

K 號：K214090 · 2022-11-01

決定日期2022-11-01

產品代碼PBX

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

Back 3 COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Swims America Corp. It received FDA 510(k) clearance on 2022-11-01 under 510(k) number K214090. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Back 3 COLOR?

Back 3 COLOR is a medical device that received FDA 510(k) clearance on 2022-11-01. The listed applicant is Swims America Corp. The 510(k) number is K214090.

When did Back 3 COLOR receive FDA 510(k) clearance?

Back 3 COLOR received FDA 510(k) clearance on 2022-11-01, under 510(k) number K214090.

Who is the listed applicant for Back 3 COLOR?

The FDA 510(k) record lists Swims America Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Back 3 COLOR?

The FDA product code for Back 3 COLOR is PBX.

其他以 Swims America Corp 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。

K230167BACK 4 K230037BACK 3 K220014RSHOCK

相關器械（代碼：PBX）

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。

K243223多療法美容治療設備（BHS 202 UNYQUE）Bh Group Us, LLC K253480Capenergy C 裝置 RF C200 及 C400 DrakarianCapenergy Medical S.L.K260647規範化醫療設備名稱：SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV 裝置Pollogen, Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。