FDA 510(k)

咬離

K 號：K160943 · 2016-08-26

決定日期2016-08-26

產品代碼IRT

諮詢委員會PM

決定相當於

器材摘要

Bite Away is the device name listed in this FDA 510(k) record. The listed applicant is Riemser Pharma. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K160943. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bite Away?

Bite Away is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Riemser Pharma. The 510(k) number is K160943.

When did Bite Away receive FDA 510(k) clearance?

Bite Away received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160943.

Who is the listed applicant for Bite Away?

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

What is the FDA product code for Bite Away?

The FDA product code for Bite Away is IRT.

相關器械（代碼：IRT）

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。

K250047咬斷兩個mibeTec GmbH K220514bite away neomibeTec GmbH

官方來源

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