FDA 510(k)

肺掃描

K 號：K191876 · 2020-03-18

決定日期2020-03-18

產品代碼PNV

諮詢委員會AN

決定相當於

器材摘要

PulmoScan is the device name listed in this FDA 510(k) record. The listed applicant is Cognita Labs, LLC. It received FDA 510(k) clearance on 2020-03-18 under 510(k) number K191876. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PulmoScan?

PulmoScan is a medical device that received FDA 510(k) clearance on 2020-03-18. The listed applicant is Cognita Labs, LLC. The 510(k) number is K191876.

When did PulmoScan receive FDA 510(k) clearance?

PulmoScan received FDA 510(k) clearance on 2020-03-18, under 510(k) number K191876.

Who is the listed applicant for PulmoScan?

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

What is the FDA product code for PulmoScan?

The FDA product code for PulmoScan is PNV.

其他以 Cognita Labs, LLC 為申請人之記錄

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K183586CapMedic

相關器械（代碼：PNV）

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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