咬合器
K号: K160943 · 2016-08-26
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决定日期2016-08-26
产品代码IRT
咨询委员会PM
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决定实质等同
器械摘要
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.
常见问题
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.
相关器械（代码：IRT）
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官方来源
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