FDA 510(k)

PROPEL 裝置

K 號：K172164 · 2018-01-17

決定日期2018-01-17

產品代碼DZJ

諮詢委員會DE

決定相當於

器材摘要

PROPEL Device is the device name listed in this FDA 510(k) record. The listed applicant is Propel Orthodontics, LLC. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K172164. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PROPEL Device?

PROPEL Device is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Propel Orthodontics, LLC. The 510(k) number is K172164.

When did PROPEL Device receive FDA 510(k) clearance?

PROPEL Device received FDA 510(k) clearance on 2018-01-17, under 510(k) number K172164.

Who is the listed applicant for PROPEL Device?

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

What is the FDA product code for PROPEL Device?

The FDA product code for PROPEL Device is DZJ.

其他以 Propel Orthodontics, LLC 為申請人之記錄

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相關器械（代碼：DZJ）

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