FDA 510(k)

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

K-번호: K214084 · 2022-01-20

결정일2022-01-20

제품 코드OAS

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K214084. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Cefla S.C.. The 510(k) number is K214084.

When did hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS receive FDA 510(k) clearance?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS received FDA 510(k) clearance on 2022-01-20, under 510(k) number K214084.

Who is the listed applicant for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

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

What is the FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

The FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is OAS.

Cefla S.C.를 신청인으로 등재한 기타 기록

K260716네오와이즈 K252353myray ProXIma X6 K230895CEFLA 치과 마이크로모터: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,K231990Apex Locator K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS K213022CEFLA 치과 마이크로모터: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, 임플란터 LED

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