FDA 510(k)

PosiSep X BAM Hemostat Dressing/Intranasal Splint

K-번호: K220326 · 2022-11-14

결정일2022-11-14

제품 코드EMX

자문 위원회EN

결정Substantially Equivalent

기기 요약

PosiSep X BAM Hemostat Dressing/Intranasal Splint is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2022-11-14 under 510(k) number K220326. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PosiSep X BAM Hemostat Dressing/Intranasal Splint?

PosiSep X BAM Hemostat Dressing/Intranasal Splint is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Hemostasis, LLC. The 510(k) number is K220326.

When did PosiSep X BAM Hemostat Dressing/Intranasal Splint receive FDA 510(k) clearance?

PosiSep X BAM Hemostat Dressing/Intranasal Splint received FDA 510(k) clearance on 2022-11-14, under 510(k) number K220326.

Who is the listed applicant for PosiSep X BAM Hemostat Dressing/Intranasal Splint?

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

What is the FDA product code for PosiSep X BAM Hemostat Dressing/Intranasal Splint?

The FDA product code for PosiSep X BAM Hemostat Dressing/Intranasal Splint is EMX.

Hemostasis, LLC를 신청인으로 등재한 기타 기록

K234131Resolv Endoscopic Hemostat System K210411PosiSep EAR Fragmentable Ear Dressing

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

기기 요약

자주 묻는 질문

관련 임상시험

Hemostasis, LLC를 신청인으로 등재한 기타 기록

공식 출처