Filter and HME/Filter
Device Facts
| Record ID | K221472 |
|---|---|
| Device Name | Filter and HME/Filter |
| Applicant | Ningbo Huakun Medical Equipment Co., Ltd. |
| Product Code | CAH · Anesthesiology |
| Decision Date | Feb 8, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5260 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
