The following data is part of a premarket notification filed by Given Imaging Ltd. (medtronic) with the FDA for Pillcam Sb 3 Capsule Endoscopy System, Pillcam Software 9.0e.
| Device ID | K211684 |
| 510k Number | K211684 |
| Device Name: | PillCam SB 3 Capsule Endoscopy System, PillCam Software 9.0E |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | Given Imaging Ltd. (Medtronic) 2 Hacarmel St. New Industrial Park, PO Box 258 Yoqneam, IL 20692 |
| Contact | Efrat Shamgar |
| Correspondent | Randy J. Prebula Hogan Lovells US LLP 555 13th Street, NW Washington, Dc, DC 20004 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-08-27 |