AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
Device Facts
| Record ID | K912651 |
|---|---|
| Device Name | AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM |
| Applicant | Stackhouse Assoc. |
| Product Code | FYD · General, Plastic Surgery |
| Decision Date | Jul 8, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.
Special Controls
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
