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510(k) K222416

RIA Safeguard by Ria Tech Co., Ltd. — Product Code FRF

K222416 is an FDA 510(k) premarket notification submitted by Ria Tech Co., Ltd. for the device "RIA Safeguard". The FDA issued a decision of Substantially Equivalent on May 1, 2023. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2023
Date Received
August 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

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  • K130702 — AIRSONETT AIR-4 (July 23, 2013)
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FDA data resources