FDA 510(k)

Anexa Wound Flush, Água Estéril e Salmão Normal Estéril

Número K: K161658 · 2016-09-14

Data da decisão2016-09-14

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is the device name listed in this FDA 510(k) record. The listed applicant is Anexa Biomedical, Inc.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K161658. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Anexa Biomedical, Inc.. The 510(k) number is K161658.

When did Anexa Wound Flush, Sterile Water & Sterile Normal Saline receive FDA 510(k) clearance?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline received FDA 510(k) clearance on 2016-09-14, under 510(k) number K161658.

Who is the listed applicant for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

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

What is the FDA product code for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

The FDA product code for Anexa Wound Flush, Sterile Water & Sterile Normal Saline is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Anexa Biomedical, Inc. como candidato(a)

K172486Anexa Wound Flush, Água Estéril USP, e Salmão Normal Estéril (cloruro de sódio 0,9%) 120 mL copo, Água Estéril, e Salmão Normal Estéril (cloruro de sódio 0,9%) 100mL garrafa, Água Estéril, e Salmão Normal Estéril (cloruro de sódio 0,9%) 250mL garrafa, Água Estéril, e Salmão Normal Estéril (cloruro de sódio 0,9%) 500mL garrafa

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