FDA 510(k)

Discovery NM 750b Bopsy

K号: K160933 · 2016-11-18

决定日期2016-11-18

产品代码IYX

咨询委员会RA

决定实质等同

器械摘要

Discovery NM 750b Bopsy is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K160933. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Discovery NM 750b Bopsy?

Discovery NM 750b Bopsy is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is GE Healthcare. The 510(k) number is K160933.

When did Discovery NM 750b Bopsy receive FDA 510(k) clearance?

Discovery NM 750b Bopsy received FDA 510(k) clearance on 2016-11-18, under 510(k) number K160933.

Who is the listed applicant for Discovery NM 750b Bopsy?

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

What is the FDA product code for Discovery NM 750b Bopsy?

The FDA product code for Discovery NM 750b Bopsy is IYX.

列明GE Healthcare为申报人的其他记录

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K253639查看此医疗设备监管文本： View the medical-device regulatory text for this device_name.K242925MR Contour DL K232346数字专家访问与远程扫描 K223212Precision DL K221680Xeleris V 处理与审查系统 K221932Omni 传奇

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