AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
Device Facts
| Record ID | K132679 |
|---|---|
| Device Name | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER |
| Applicant | Galemed Corp. |
| Product Code | CAH · Anesthesiology |
| Decision Date | Apr 18, 2014 |
| 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.