FDA 510(k)

螺旋感測器型號 2015-E

K 號：K161454 · 2016-11-01

決定日期2016-11-01

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Propeller Sensor Model 2015-E is the device name listed in this FDA 510(k) record. The listed applicant is Reciprocal Labs Corporation. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K161454. 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 Sensor Model 2015-E?

Propeller Sensor Model 2015-E is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Reciprocal Labs Corporation. The 510(k) number is K161454.

When did Propeller Sensor Model 2015-E receive FDA 510(k) clearance?

Propeller Sensor Model 2015-E received FDA 510(k) clearance on 2016-11-01, under 510(k) number K161454.

Who is the listed applicant for Propeller Sensor Model 2015-E?

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

What is the FDA product code for Propeller Sensor Model 2015-E?

The FDA product code for Propeller Sensor Model 2015-E is CAF.

其他以 Reciprocal Labs Corporation 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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