FDA 510(k)

Aero Chrome* Select Camisas quirúrgicas de rendimiento respirable

N.º K: K162930 · 2017-04-21

Fecha de decisión2017-04-21

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aero Chrome* Select Breathable Performance Surgical Gowns 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 2017-04-21 under 510(k) number K162930. 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* Select Breathable Performance Surgical Gowns?

Aero Chrome* Select Breathable Performance Surgical Gowns is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Halyard Health, Inc.. The 510(k) number is K162930.

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

Aero Chrome* Select Breathable Performance Surgical Gowns received FDA 510(k) clearance on 2017-04-21, under 510(k) number K162930.

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

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* Select Breathable Performance Surgical Gowns?

The FDA product code for Aero Chrome* Select Breathable Performance Surgical Gowns 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 K163461Coolief* Cooled RF Probe K163236COOLIEF Cooled Radiofrequency Kit K153255Aero Chrome* Camisa quirúrgica de rendimiento respirable

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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