21 CFR 880.5450 — Chamber, Reverse Isolation, Patient Care
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5450
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FRR | Chamber, Reverse Isolation, Patient Care | 2 | 1 | 3rd Party |
| LGM | Chamber, Patient Isolation | 2 | 12 | 3rd Party |
| LGN | Chamber, Patient Transport Isolation | 2 | 2 | 3rd Party |
