FDA 510(k)

12MP 彩色数字乳腺摄影 LCD 显示器 CL-S1200

K号: K203733 · 2021-06-29

决定日期2021-06-29

产品代码PGY

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Jvckenwood Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K2411053MP 彩色 LCD 显示器 (CL-S301)K2228648MP彩色液晶显示器CL-R813 K2129856MP 彩色 LCD 显示器 CL-S600 K2103452MP 单色 LCD 显示器 MS-S200 K2001613MP 单色数字乳腺摄影 LCD 显示器 MS-S300 K1911375MP 彩色液晶显示器 CL-S500，5MP 单色液晶显示器 MS-S500

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官方来源

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