510(k) K991355
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2000
- Date Received
- April 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type