510(k) K222917

Breathing circuit bacterial/viral filter by Shaoxing Haitech Medical Products Co., Ltd. — Product Code CAH

K222917 is an FDA 510(k) premarket notification submitted by Shaoxing Haitech Medical Products Co., Ltd. for the device "Breathing circuit bacterial/viral filter". The FDA issued a decision of Substantially Equivalent on February 15, 2024. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2024
Date Received
September 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type