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FDA 510(k)

MS-39

K号: K221601 · 2023-09-01

申请人C.S.O. S.R.L.
决定日期2023-09-01
产品代码OBO
咨询委员会OP 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

MS-39 is the device name listed in this FDA 510(k) record. The listed applicant is C.S.O. S.R.L.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K221601. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MS-39?

MS-39 is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is C.S.O. S.R.L.. The 510(k) number is K221601.

When did MS-39 receive FDA 510(k) clearance?

MS-39 received FDA 510(k) clearance on 2023-09-01, under 510(k) number K221601.

Who is the listed applicant for MS-39?

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

What is the FDA product code for MS-39?

The FDA product code for MS-39 is OBO.

相关器械(代码:OBO)

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