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FDA 510(k)

螺旋感測器用於Neohaler

K 號:K180770 · 2018-08-01

決定日期2018-08-01
產品代碼CAF
諮詢委員會AN
決定相當於

器材摘要

Propeller Sensor for Neohaler 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 2018-08-01 under 510(k) number K180770. 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 for Neohaler?

Propeller Sensor for Neohaler is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Reciprocal Labs Corporation. The 510(k) number is K180770.

When did Propeller Sensor for Neohaler receive FDA 510(k) clearance?

Propeller Sensor for Neohaler received FDA 510(k) clearance on 2018-08-01, under 510(k) number K180770.

Who is the listed applicant for Propeller Sensor for Neohaler?

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 for Neohaler?

The FDA product code for Propeller Sensor for Neohaler is CAF.

相關臨床試驗

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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。

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。

官方來源

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