FDA 510(k)

Oral Device OA, Oral Device S

K-번호: K181396 · 2018-11-16

신청자Passion For Life Healthcare (Uk) Limited

결정일2018-11-16

제품 코드LRK

자문 위원회DE

결정Substantially Equivalent

기기 요약

Oral Device OA, Oral Device S is the device name listed in this FDA 510(k) record. The listed applicant is Passion For Life Healthcare (Uk) Limited. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181396. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Oral Device OA, Oral Device S?

Oral Device OA, Oral Device S is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Passion For Life Healthcare (Uk) Limited. The 510(k) number is K181396.

When did Oral Device OA, Oral Device S receive FDA 510(k) clearance?

Oral Device OA, Oral Device S received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181396.

Who is the listed applicant for Oral Device OA, Oral Device S?

The FDA 510(k) record lists Passion For Life Healthcare (Uk) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oral Device OA, Oral Device S?

The FDA product code for Oral Device OA, Oral Device S is LRK.

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Oral Device OA, Oral Device S

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LRK)

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