Chamber, Patient Transport Isolation
A patient transport isolation chamber is a portable enclosure used to safely transport patients who require isolation due to severe immunosuppression or highly infectious disease, maintaining a controlled environment between clinical areas or facilities. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LGN and is regulated under 21 CFR 880.5450 within the General Hospital specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LGN
- Device Class
- FDA class 2
- Regulation Number
- 880.5450
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.