510(k) K240276
PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software by
Given Imaging Ltd. (D.B.A. Medtronic)
— Product Code NEZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2024
- Date Received
- January 31, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Gastrointestinal, Wireless, Capsule
- Device Class
- Class II
- Regulation Number
- 876.1300
- Review Panel
- GU
- Submission Type