FRR · Chamber, Reverse Isolation, Patient Care
General Hospital · 21 CFR 880.5450 · Class 2
Overview
| Product Code | FRR |
|---|---|
| Device Name | Chamber, Reverse Isolation, Patient Care |
| Regulation | 21 CFR 880.5450 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K922110 | GO-CLEAN | Viva-Tek Assoc., Inc. | Mar 9, 1994 | SESE |
Top Applicants
- Viva-Tek Assoc., Inc. — 1 clearance
