FDA 510(k)

體重管理電動定位系統（BPPS）

K 號：K182995 · 2019-03-08

決定日期2019-03-08

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Bariatric Power Positioning System (BPPS) is the device name listed in this FDA 510(k) record. The listed applicant is Motion Concepts. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K182995. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bariatric Power Positioning System (BPPS)?

Bariatric Power Positioning System (BPPS) is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is Motion Concepts. The 510(k) number is K182995.

When did Bariatric Power Positioning System (BPPS) receive FDA 510(k) clearance?

Bariatric Power Positioning System (BPPS) received FDA 510(k) clearance on 2019-03-08, under 510(k) number K182995.

Who is the listed applicant for Bariatric Power Positioning System (BPPS)?

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

What is the FDA product code for Bariatric Power Positioning System (BPPS)?

The FDA product code for Bariatric Power Positioning System (BPPS) is ITI.

其他以 Motion Concepts 為申請人之記錄

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K191376模組化站立式電力系統

相關器械（代碼：ITI）

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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官方來源

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