MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
Device Facts
| Record ID | K912444 |
|---|---|
| Device Name | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM |
| Applicant | Radiometer America, Inc. |
| Product Code | LGM · General Hospital |
| Decision Date | Feb 18, 1992 |
| 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.
