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FDA 510(k)

Sterile Water for Inhalation in 1L Flexoval ® bottles.

N.º K: K223551 · 2023-08-03

SolicitanteHometa, Inc.
Fecha de decisión2023-08-03
Código de productoBTT
Comité asesorAN
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Water for Inhalation in 1L Flexoval ® bottles. is the device name listed in this FDA 510(k) record. The listed applicant is Hometa, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K223551. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sterile Water for Inhalation in 1L Flexoval ® bottles.?

Sterile Water for Inhalation in 1L Flexoval ® bottles. is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Hometa, Inc.. The 510(k) number is K223551.

When did Sterile Water for Inhalation in 1L Flexoval ® bottles. receive FDA 510(k) clearance?

Sterile Water for Inhalation in 1L Flexoval ® bottles. received FDA 510(k) clearance on 2023-08-03, under 510(k) number K223551.

Who is the listed applicant for Sterile Water for Inhalation in 1L Flexoval ® bottles.?

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

What is the FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles.?

The FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles. is BTT.

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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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