FDA 510(k)

純斜角

K 號：K152021 · 2016-03-31

決定日期2016-03-31

產品代碼IOR

諮詢委員會PM

決定相當於

器材摘要

Pure Tilt is the device name listed in this FDA 510(k) record. The listed applicant is Proactive Comfort, LLC. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K152021. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pure Tilt?

Pure Tilt is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Proactive Comfort, LLC. The 510(k) number is K152021.

When did Pure Tilt receive FDA 510(k) clearance?

Pure Tilt received FDA 510(k) clearance on 2016-03-31, under 510(k) number K152021.

Who is the listed applicant for Pure Tilt?

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

What is the FDA product code for Pure Tilt?

The FDA product code for Pure Tilt is IOR.

相關器械（代碼：IOR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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