FDA 510(k)

Celesteion, PCA-9000A/3

K 號：K170490 · 2017-06-01

決定日期2017-06-01

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

Celesteion, PCA-9000A/3 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170490. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Celesteion, PCA-9000A/3?

Celesteion, PCA-9000A/3 is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170490.

When did Celesteion, PCA-9000A/3 receive FDA 510(k) clearance?

Celesteion, PCA-9000A/3 received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170490.

Who is the listed applicant for Celesteion, PCA-9000A/3?

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

What is the FDA product code for Celesteion, PCA-9000A/3?

The FDA product code for Celesteion, PCA-9000A/3 is KPS.

其他以 Toshibamedical Systems Corporation 為申請人之記錄

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相關器械（代碼：KPS）

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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