FDA 510(k)

Bodygard SFS Surgical Gown Level 4

Номер K: K221139 · 2022-11-10

ЗаявительFeliks Plastik Laminasyon VE Ambalaj Malzemeleri

Дата решения2022-11-10

Код продуктаFYA

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Bodygard SFS Surgical Gown Level 4 is the device name listed in this FDA 510(k) record. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221139. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Bodygard SFS Surgical Gown Level 4?

Bodygard SFS Surgical Gown Level 4 is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri. The 510(k) number is K221139.

When did Bodygard SFS Surgical Gown Level 4 receive FDA 510(k) clearance?

Bodygard SFS Surgical Gown Level 4 received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221139.

Who is the listed applicant for Bodygard SFS Surgical Gown Level 4?

The FDA 510(k) record lists Feliks Plastik Laminasyon VE Ambalaj Malzemeleri as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bodygard SFS Surgical Gown Level 4?

The FDA product code for Bodygard SFS Surgical Gown Level 4 is FYA.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: FYA)

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

Официальный источник

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