FDA 510(k)

螺旋感測器型號 2014-R

K 號：K152482 · 2016-03-04

決定日期2016-03-04

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Propeller Sensor Model 2014-R is the device name listed in this FDA 510(k) record. The listed applicant is Reciprocal Labs. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K152482. 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 2014-R?

Propeller Sensor Model 2014-R is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Reciprocal Labs. The 510(k) number is K152482.

When did Propeller Sensor Model 2014-R receive FDA 510(k) clearance?

Propeller Sensor Model 2014-R received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152482.

Who is the listed applicant for Propeller Sensor Model 2014-R?

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 Sensor Model 2014-R?

The FDA product code for Propeller Sensor Model 2014-R is CAF.

其他以 Reciprocal Labs 為申請人之記錄

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K152882螺旋系統

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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