The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Pillcam Platform With Pillcam Sb Capsuleswith Pillcam R Sensorbelt.
| Device ID | K103088 |
| 510k Number | K103088 |
| Device Name: | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. HERMON BUILDING NEW INDUSTRIAL PARK PO BOX 258 Yoqneam, IL 20692 |
| Contact | Tim Thomas |
| Correspondent | Tim Thomas GIVEN IMAGING LTD. HERMON BUILDING NEW INDUSTRIAL PARK PO BOX 258 Yoqneam, IL 20692 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2011-01-14 |
| Summary: | summary |