510(k) K222917
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