FDA 510(k)

고성능 항균 고무화 섬유 (아연으로 처리된)

K-번호: K210974 · 2021-05-12

결정일2021-05-12

제품 코드FRO

결정대체적으로 동일

기기 요약

High Performance Antimicrobial Gelling Fiber with Silver is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2021-05-12 under 510(k) number K210974. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the High Performance Antimicrobial Gelling Fiber with Silver?

High Performance Antimicrobial Gelling Fiber with Silver is a medical device that received FDA 510(k) clearance on 2021-05-12. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K210974.

When did High Performance Antimicrobial Gelling Fiber with Silver receive FDA 510(k) clearance?

High Performance Antimicrobial Gelling Fiber with Silver received FDA 510(k) clearance on 2021-05-12, under 510(k) number K210974.

Who is the listed applicant for High Performance Antimicrobial Gelling Fiber with Silver?

The FDA 510(k) record lists Advanced Medical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Performance Antimicrobial Gelling Fiber with Silver?

The FDA product code for High Performance Antimicrobial Gelling Fiber with Silver is FRO. This falls under the Anesthesiology category.

Advanced Medical Solutions, Ltd.를 신청인으로 등재한 기타 기록

K213473PHMB를 포함한 항균 고무 섬유 접착제 K190819실리콘 PHMB 부상 치료 패치 K183645실버 고성능 드레싱 K180634수술용 은 포스트 오퍼레이티브 드레싱 K181197PHMB 표면 접착성 부상 치료 패치 K163062PHMB 항균泡沫 상처 치료 패치

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