510(k) K102127
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2010
- Date Received
- July 29, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Changer, Tube, Endotracheal
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type