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FDA 510(k)

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops

N.º K: K221209 · 2023-03-08

SolicitantePadm Medical, Inc.
Fecha de decisión2023-03-08
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is the device name listed in this FDA 510(k) record. The listed applicant is Padm Medical, Inc.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K221209. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Padm Medical, Inc.. The 510(k) number is K221209.

When did PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops receive FDA 510(k) clearance?

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops received FDA 510(k) clearance on 2023-03-08, under 510(k) number K221209.

Who is the listed applicant for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

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

What is the FDA product code for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

The FDA product code for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is FXX.

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Dispositivos relacionados (Código: FXX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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