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FDA 510(k)

Copper Foam Dressing (Prescription and OTC)

K-Number: K231088 · 2024-01-11

ApplicantRoosin Medical Co., Ltd.
Decision Date2024-01-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Copper Foam Dressing (Prescription and OTC) is a medical device manufactured by Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-01-11 under approval number K231088. 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.

Frequently Asked Questions

What is the Copper Foam Dressing (Prescription and OTC)?

Copper Foam Dressing (Prescription and OTC) is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Roosin Medical Co., Ltd.. The 510(k) number is K231088.

When was Copper Foam Dressing (Prescription and OTC) approved by the FDA?

Copper Foam Dressing (Prescription and OTC) received FDA 510(k) clearance on 2024-01-11, under approval number K231088.

What company makes Copper Foam Dressing (Prescription and OTC)?

Copper Foam Dressing (Prescription and OTC) is manufactured by Roosin Medical Co., Ltd..

What is the FDA product code for Copper Foam Dressing (Prescription and OTC)?

The FDA product code for Copper Foam Dressing (Prescription and OTC) is FRO. This falls under the Anesthesiology category.

Other Devices by Roosin Medical Co., Ltd.

K181478Roosin Xeroform Petrolatum Dressing K230190Polyver Silver Alginate Dressing (Prescription and OTC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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