LGN · Chamber, Patient Transport Isolation
General Hospital · 21 CFR 880.5450 · Class 2
Overview
| Product Code | LGN |
|---|---|
| Device Name | Chamber, Patient Transport Isolation |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052798 | CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C | Isovac Products, LLC | Jun 6, 2006 | SESE |
| K790658 | AIRCRAFT TRANSIT ISOLATOR MODEL 121 | Vickers America Medical Corp. | Jul 3, 1979 | SESE |
Top Applicants
- Isovac Products, LLC — 1 clearance
- Vickers America Medical Corp. — 1 clearance
