K222917
- 510(k) number
- K222917
- Device name
- Breathing circuit bacterial/viral filter
- Applicant
- Shaoxing Haitech Medical Products Co., Ltd. CN
- Product code
- CAH — Filter, Bacterial, Breathing-Circuit
- Decision date
- 2024-02-15
- Date received
- 2022-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K222917
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.