510(k) DEN060009
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 8, 2007
- Date Received
- October 3, 2006
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- Device Class
- Class II
- Regulation Number
- 880.6260
- Review Panel
- HO
- Submission Type
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.