510(k) K180253
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2018
- Date Received
- January 30, 2018
- 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