510(k) K103696
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 2011
- Date Received
- December 17, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Air, Non-Manual, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type