FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
Device Facts
| Record ID | K063125 |
|---|---|
| Device Name | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) |
| Applicant | Arc Medical, Inc. |
| Product Code | CAH · Anesthesiology |
| Decision Date | Apr 13, 2007 |
| 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.
