ISOLATION MASK I.C.S.
Device Facts
| Record ID | K831062 |
|---|---|
| Device Name | ISOLATION MASK I.C.S. |
| Applicant | American Threshold Industries, Inc. |
| Product Code | LGM · General Hospital |
| Decision Date | Apr 13, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5450 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.
