GO-PEN®
K-번호: K250262 · 2025-04-24
광고
기기 요약
GO-PEN® is the device name listed in this FDA 510(k) record. The listed applicant is Go-Pen Aps. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250262. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the GO-PEN®?
GO-PEN® is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Go-Pen Aps. The 510(k) number is K250262.
When did GO-PEN® receive FDA 510(k) clearance?
GO-PEN® received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250262.
Who is the listed applicant for GO-PEN®?
The FDA 510(k) record lists Go-Pen Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GO-PEN®?
The FDA product code for GO-PEN® is FMF.
관련 기기 (코드: FMF)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
광고