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FDA 510(k)

IDSS 力三角控制模組

K 號:K153205 · 2016-08-01

決定日期2016-08-01
產品代碼ODA
諮詢委員會GU
決定相當於

器材摘要

IDSS ForceTriad Control Module is the device name listed in this FDA 510(k) record. The listed applicant is Black Diamond Video, Inc.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K153205. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IDSS ForceTriad Control Module?

IDSS ForceTriad Control Module is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Black Diamond Video, Inc.. The 510(k) number is K153205.

When did IDSS ForceTriad Control Module receive FDA 510(k) clearance?

IDSS ForceTriad Control Module received FDA 510(k) clearance on 2016-08-01, under 510(k) number K153205.

Who is the listed applicant for IDSS ForceTriad Control Module?

The FDA 510(k) record lists Black Diamond Video, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDSS ForceTriad Control Module?

The FDA product code for IDSS ForceTriad Control Module is ODA.

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相關器械(代碼:ODA)

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。

官方來源

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