FDA 510(k)

아바지아 OTC TENS 미용용, 모델 BEST-AV1™: EZZI-LIFT™ 장치

K-번호: K191951 · 2021-04-27

결정일2021-04-27

제품 코드NFO

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is the device name listed in this FDA 510(k) record. The listed applicant is Avazzia, Inc.. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K191951. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device?

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Avazzia, Inc.. The 510(k) number is K191951.

When did Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device receive FDA 510(k) clearance?

Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device received FDA 510(k) clearance on 2021-04-27, under 510(k) number K191951.

Who is the listed applicant for Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device?

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

What is the FDA product code for Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device?

The FDA product code for Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is NFO.

Avazzia, Inc.를 신청인으로 등재한 기타 기록

K162392아바지아

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