FDA 510(k)

AFIAS iFOB with AFIAS-50

K号: K163225 · 2017-08-08

决定日期2017-08-08

产品代码OOX

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

AFIAS iFOB with AFIAS-50 is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2017-08-08 under 510(k) number K163225. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AFIAS iFOB with AFIAS-50?

AFIAS iFOB with AFIAS-50 is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Immunostics Inc.,. The 510(k) number is K163225.

When did AFIAS iFOB with AFIAS-50 receive FDA 510(k) clearance?

AFIAS iFOB with AFIAS-50 received FDA 510(k) clearance on 2017-08-08, under 510(k) number K163225.

Who is the listed applicant for AFIAS iFOB with AFIAS-50?

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

What is the FDA product code for AFIAS iFOB with AFIAS-50?

The FDA product code for AFIAS iFOB with AFIAS-50 is OOX.

列明Immunostics Inc.,为申报人的其他记录

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