FDA 510(k)

Aero Chrome* Camisa quirúrgica de rendimiento respirable

N.º K: K153255 · 2016-04-13

Fecha de decisión2016-04-13

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aero Chrome* Breathable Performance Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health, Inc.. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K153255. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aero Chrome* Breathable Performance Surgical Gown?

Aero Chrome* Breathable Performance Surgical Gown is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is Halyard Health, Inc.. The 510(k) number is K153255.

When did Aero Chrome* Breathable Performance Surgical Gown receive FDA 510(k) clearance?

Aero Chrome* Breathable Performance Surgical Gown received FDA 510(k) clearance on 2016-04-13, under 510(k) number K153255.

Who is the listed applicant for Aero Chrome* Breathable Performance Surgical Gown?

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

What is the FDA product code for Aero Chrome* Breathable Performance Surgical Gown?

The FDA product code for Aero Chrome* Breathable Performance Surgical Gown is FYA.

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Otros registros que enlistan a Halyard Health, Inc. como solicitante

K173955Mic-Key* SF Over-the-Wire Stoma Measuring Device K162930Aero Chrome* Select Camisas quirúrgicas de rendimiento respirable K163461Coolief* Cooled RF Probe K163236COOLIEF Cooled Radiofrequency Kit

Dispositivos relacionados (Código: 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

Fuente oficial

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