FDA 510(k)

tün® ultrasonic tips product family

K-번호: K182145 · 2019-06-07

결정일2019-06-07

제품 코드ELC

자문 위원회의료 장비 규제 텍스트 번역 DE [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료 장비로, 510(k) 신청을 통해 승인을 받았습니다. 이 제품은 PMA(Premarket Approval)를 받지 않았으며, NCT(National Clinical Trial) 등록 번호는 [NCT 번호]입니다. PMID(Publication Medical Identifier)은 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

결정Substantially Equivalent

기기 요약

tün® ultrasonic tips product family is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Endodontics. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K182145. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the tün® ultrasonic tips product family?

tün® ultrasonic tips product family is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Engineered Endodontics. The 510(k) number is K182145.

When did tün® ultrasonic tips product family receive FDA 510(k) clearance?

tün® ultrasonic tips product family received FDA 510(k) clearance on 2019-06-07, under 510(k) number K182145.

Who is the listed applicant for tün® ultrasonic tips product family?

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

What is the FDA product code for tün® ultrasonic tips product family?

The FDA product code for tün® ultrasonic tips product family is ELC.

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tün® ultrasonic tips product family

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: ELC)

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