FDA 510(k)

Clyra Wound Irrigation Solution

Número K: K181428 · 2019-09-20

RequerenteClyra Medical Technologies, Inc.

Data da decisão2019-09-20

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clyra Wound Irrigation Solution is the device name listed in this FDA 510(k) record. The listed applicant is Clyra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K181428. 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 Clyra Wound Irrigation Solution?

Clyra Wound Irrigation Solution is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Clyra Medical Technologies, Inc.. The 510(k) number is K181428.

When did Clyra Wound Irrigation Solution receive FDA 510(k) clearance?

Clyra Wound Irrigation Solution received FDA 510(k) clearance on 2019-09-20, under 510(k) number K181428.

Who is the listed applicant for Clyra Wound Irrigation Solution?

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

What is the FDA product code for Clyra Wound Irrigation Solution?

The FDA product code for Clyra Wound Irrigation Solution is FRO. This falls under the Anesthesiology category.

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