FDA 510(k)

AMSure® Single Use Saline Topical Solution

Número K: K201138 · 2021-04-14

Data da decisão2021-04-14

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

AMSure® Single Use Saline Topical Solution is the device name listed in this FDA 510(k) record. The listed applicant is Amsino Medical, Inc.. It received FDA 510(k) clearance on 2021-04-14 under 510(k) number K201138. 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 AMSure® Single Use Saline Topical Solution?

AMSure® Single Use Saline Topical Solution is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Amsino Medical, Inc.. The 510(k) number is K201138.

When did AMSure® Single Use Saline Topical Solution receive FDA 510(k) clearance?

AMSure® Single Use Saline Topical Solution received FDA 510(k) clearance on 2021-04-14, under 510(k) number K201138.

Who is the listed applicant for AMSure® Single Use Saline Topical Solution?

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

What is the FDA product code for AMSure® Single Use Saline Topical Solution?

The FDA product code for AMSure® Single Use Saline Topical Solution is FRO. This falls under the Anesthesiology category.

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