FDA 510(k)

BIOCHARGE

K 號：K241912 · 2024-07-29

決定日期2024-07-29

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

BIOCHARGE is the device name listed in this FDA 510(k) record. The listed applicant is Nanofiber Solutions, LLC. It received FDA 510(k) clearance on 2024-07-29 under 510(k) number K241912. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOCHARGE?

BIOCHARGE is a medical device that received FDA 510(k) clearance on 2024-07-29. The listed applicant is Nanofiber Solutions, LLC. The 510(k) number is K241912.

When did BIOCHARGE receive FDA 510(k) clearance?

BIOCHARGE received FDA 510(k) clearance on 2024-07-29, under 510(k) number K241912.

Who is the listed applicant for BIOCHARGE?

The FDA 510(k) record lists Nanofiber Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCHARGE?

The FDA product code for BIOCHARGE is MAI.

其他以 Nanofiber Solutions, 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：MAI）

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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