FDA 510(k)

螺旋系統

K 號：K152882 · 2016-03-08

決定日期2016-03-08

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Propeller System is the device name listed in this FDA 510(k) record. The listed applicant is Reciprocal Labs. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K152882. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Propeller System?

Propeller System is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Reciprocal Labs. The 510(k) number is K152882.

When did Propeller System receive FDA 510(k) clearance?

Propeller System received FDA 510(k) clearance on 2016-03-08, under 510(k) number K152882.

Who is the listed applicant for Propeller System?

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

What is the FDA product code for Propeller System?

The FDA product code for Propeller System is CAF.

其他以 Reciprocal Labs 為申請人之記錄

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K152482螺旋感測器型號 2014-R

相關器械（代碼：CAF）

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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