FDA 510(k)

CipherOx CRI M1

K 號：K173929 · 2018-07-24

決定日期2018-07-24

產品代碼PPW

諮詢委員會履歷

決定相當於

器材摘要

CipherOx CRI M1 is the device name listed in this FDA 510(k) record. The listed applicant is Flashback Technologies, Inc.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K173929. The device is classified under product code PPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CipherOx CRI M1?

CipherOx CRI M1 is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Flashback Technologies, Inc.. The 510(k) number is K173929.

When did CipherOx CRI M1 receive FDA 510(k) clearance?

CipherOx CRI M1 received FDA 510(k) clearance on 2018-07-24, under 510(k) number K173929.

Who is the listed applicant for CipherOx CRI M1?

The FDA 510(k) record lists Flashback Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CipherOx CRI M1?

The FDA product code for CipherOx CRI M1 is PPW.

其他以 Flashback Technologies, Inc. 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。

K213255CipherOx CRI 製劑

相關器械（代碼：PPW）

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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