FDA 510(k)

Blue Sky Bio 计算机正畸托槽系统

K号: K182338 · 2018-11-09

决定日期2018-11-09

产品代码DYW

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决定实质等同

器械摘要

Blue Sky Bio Computerized Orthodontic Bracket System is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182338. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Blue Sky Bio Computerized Orthodontic Bracket System?

Blue Sky Bio Computerized Orthodontic Bracket System is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Blue Sky Bio. The 510(k) number is K182338.

When did Blue Sky Bio Computerized Orthodontic Bracket System receive FDA 510(k) clearance?

Blue Sky Bio Computerized Orthodontic Bracket System received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182338.

Who is the listed applicant for Blue Sky Bio Computerized Orthodontic Bracket System?

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

What is the FDA product code for Blue Sky Bio Computerized Orthodontic Bracket System?

The FDA product code for Blue Sky Bio Computerized Orthodontic Bracket System is DYW.

列明Blue Sky Bio为申报人的其他记录

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官方来源

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