510(k) K093888
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2010
- Date Received
- December 18, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5740
- Review Panel
- AN
- Submission Type