FDA 510(k)

TruGuard Custom Tongue and Jaw Positioner

K-번호: K153270 · 2016-03-08

결정일2016-03-08

제품 코드IYE

자문 위원회RA

결정Substantially Equivalent

기기 요약

TruGuard Custom Tongue and Jaw Positioner is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K153270. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TruGuard Custom Tongue and Jaw Positioner?

TruGuard Custom Tongue and Jaw Positioner is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Bionix Development Corp.. The 510(k) number is K153270.

When did TruGuard Custom Tongue and Jaw Positioner receive FDA 510(k) clearance?

TruGuard Custom Tongue and Jaw Positioner received FDA 510(k) clearance on 2016-03-08, under 510(k) number K153270.

Who is the listed applicant for TruGuard Custom Tongue and Jaw Positioner?

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

What is the FDA product code for TruGuard Custom Tongue and Jaw Positioner?

The FDA product code for TruGuard Custom Tongue and Jaw Positioner is IYE.

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TruGuard Custom Tongue and Jaw Positioner

기기 요약

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관련 임상시험

관련 기기 (코드: IYE)

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