FDA 510(k)

法克生生物技術標本射線攝影系統

K 號：K170786 · 2017-07-18

決定日期2017-07-18

產品代碼MWP

諮詢委員會RA

決定相當於

器材摘要

Faxitron Bioptics Speciemen Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K170786. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Faxitron Bioptics Speciemen Radiography System?

Faxitron Bioptics Speciemen Radiography System is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Faxitron Bioptics, LLC. The 510(k) number is K170786.

When did Faxitron Bioptics Speciemen Radiography System receive FDA 510(k) clearance?

Faxitron Bioptics Speciemen Radiography System received FDA 510(k) clearance on 2017-07-18, under 510(k) number K170786.

Who is the listed applicant for Faxitron Bioptics Speciemen Radiography System?

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

What is the FDA product code for Faxitron Bioptics Speciemen Radiography System?

The FDA product code for Faxitron Bioptics Speciemen Radiography System is MWP.

其他以 Faxitron Bioptics, LLC 為申請人之記錄

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