FDA 510(k)

VibraPEP

K-번호: K153441 · 2016-03-25

결정일2016-03-25

제품 코드BWF

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

VibraPEP is the device name listed in this FDA 510(k) record. The listed applicant is Medica Holdings, LLC. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K153441. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the VibraPEP?

VibraPEP is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Medica Holdings, LLC. The 510(k) number is K153441.

When did VibraPEP receive FDA 510(k) clearance?

VibraPEP received FDA 510(k) clearance on 2016-03-25, under 510(k) number K153441.

Who is the listed applicant for VibraPEP?

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

What is the FDA product code for VibraPEP?

The FDA product code for VibraPEP is BWF.

Medica Holdings, LLC를 신청인으로 등재한 기타 기록

K172956의약품 점막 분말기 K163091VibraPEP

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