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FDA 510(k)

藥療設備

K 號:K191987 · 2019-11-27

決定日期2019-11-27
產品代碼OLR
決定相當於

器材摘要

Orapeutic is the device name listed in this FDA 510(k) record. The listed applicant is Forward Science. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K191987. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

常見問題

What is the Orapeutic?

Orapeutic is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Forward Science. The 510(k) number is K191987.

When did Orapeutic receive FDA 510(k) clearance?

Orapeutic received FDA 510(k) clearance on 2019-11-27, under 510(k) number K191987.

Who is the listed applicant for Orapeutic?

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

What is the FDA product code for Orapeutic?

The FDA product code for Orapeutic is OLR.

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相關器械(代碼:OLR)

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。

官方來源

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