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FDA 510(k)

Hang&Go PAC

K号: K161613 · 2016-12-28

申请人Rand S.R.L.
决定日期2016-12-28
产品代码LGZ
咨询委员会医疗设备监管文本翻译如下: HO 请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Hang&Go PAC is the device name listed in this FDA 510(k) record. The listed applicant is Rand S.R.L.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K161613. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hang&Go PAC?

Hang&Go PAC is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Rand S.R.L.. The 510(k) number is K161613.

When did Hang&Go PAC receive FDA 510(k) clearance?

Hang&Go PAC received FDA 510(k) clearance on 2016-12-28, under 510(k) number K161613.

Who is the listed applicant for Hang&Go PAC?

The FDA 510(k) record lists Rand S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hang&Go PAC?

The FDA product code for Hang&Go PAC is LGZ.

相关器械(代码:LGZ)

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