Product code LGN— General Hospital
AIRCRAFT TRANSIT ISOLATOR MODEL 121
- Classification name
- Chamber, Patient Transport Isolation
- Device class
- Class 2
- Regulation
- 21 CFR 880.5450
- Advisory panel
- General Hospital
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LGN
FDA has cleared devices under product code LGN between 1979 and 2006, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2006
- 1979
Top applicants under product code LGN
Recent clearances under product code LGN
Data sourced from openFDA. This site is unofficial and independent of the FDA.