FDA 510(k)

12MP 彩色數字乳房攝影 LCD 監視器 CL-S1200

K 號：K203733 · 2021-06-29

決定日期2021-06-29

產品代碼PGY

諮詢委員會RA

決定相當於

器材摘要

12MP Color Digital Mammography LCD Monitor CL-S1200 is the device name listed in this FDA 510(k) record. The listed applicant is Jvckenwood Corporation. It received FDA 510(k) clearance on 2021-06-29 under 510(k) number K203733. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 12MP Color Digital Mammography LCD Monitor CL-S1200?

12MP Color Digital Mammography LCD Monitor CL-S1200 is a medical device that received FDA 510(k) clearance on 2021-06-29. The listed applicant is Jvckenwood Corporation. The 510(k) number is K203733.

When did 12MP Color Digital Mammography LCD Monitor CL-S1200 receive FDA 510(k) clearance?

12MP Color Digital Mammography LCD Monitor CL-S1200 received FDA 510(k) clearance on 2021-06-29, under 510(k) number K203733.

Who is the listed applicant for 12MP Color Digital Mammography LCD Monitor CL-S1200?

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

What is the FDA product code for 12MP Color Digital Mammography LCD Monitor CL-S1200?

The FDA product code for 12MP Color Digital Mammography LCD Monitor CL-S1200 is PGY.

其他以 Jvckenwood Corporation 為申請人之記錄

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相關器械（代碼：PGY）

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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