FDA 510(k)

RoyalGuard Surgical Gown, i600, Breathable

K-번호: K172445 · 2017-12-08

신청자Gri Medical & Electrical Technology Co., Ltd.

결정일2017-12-08

제품 코드FYA

자문 위원회SU

결정Substantially Equivalent

기기 요약

RoyalGuard Surgical Gown, i600, Breathable is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K172445. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the RoyalGuard Surgical Gown, i600, Breathable?

RoyalGuard Surgical Gown, i600, Breathable is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K172445.

When did RoyalGuard Surgical Gown, i600, Breathable receive FDA 510(k) clearance?

RoyalGuard Surgical Gown, i600, Breathable received FDA 510(k) clearance on 2017-12-08, under 510(k) number K172445.

Who is the listed applicant for RoyalGuard Surgical Gown, i600, Breathable?

The FDA 510(k) record lists Gri Medical & Electrical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RoyalGuard Surgical Gown, i600, Breathable?

The FDA product code for RoyalGuard Surgical Gown, i600, Breathable is FYA.

Gri Medical & Electrical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K163191ComfortGuard Surgical Gown, i600, Film Reinforced K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

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