LGN — Chamber, Patient Transport Isolation Class II
FDA product code LGN covers "Chamber, Patient Transport Isolation", a Class II medical device regulated under 21 CFR 880.5450. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LGN
- Device Class
- Class II
- Regulation Number
- 880.5450
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No