FDA 510(k)

eCarbon IBDs

K 號：K191537 · 2019-09-26

決定日期2019-09-26

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

eCarbon IBDs is the device name listed in this FDA 510(k) record. The listed applicant is Back 2 Basics Direct, LLC. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K191537. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eCarbon IBDs?

eCarbon IBDs is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Back 2 Basics Direct, LLC. The 510(k) number is K191537.

When did eCarbon IBDs receive FDA 510(k) clearance?

eCarbon IBDs received FDA 510(k) clearance on 2019-09-26, under 510(k) number K191537.

Who is the listed applicant for eCarbon IBDs?

The FDA 510(k) record lists Back 2 Basics Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eCarbon IBDs?

The FDA product code for eCarbon IBDs is ODP.

其他以 Back 2 Basics Direct, 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。

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相關器械（代碼：ODP）

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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