The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Pillcam Platform With Rapid 6.5 / Given Pillcam Platform With Pillcam Eso 3 Capsules.
| Device ID | K103025 |
| 510k Number | K103025 |
| Device Name: | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. P.O. BOX 258 NEW INDUSTRIAL PARK Yoqneam, IL 20692 |
| Contact | Tim Thomas |
| Correspondent | Tim Thomas GIVEN IMAGING LTD. P.O. BOX 258 NEW INDUSTRIAL PARK 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 | 2010-10-12 |
| Decision Date | 2011-05-13 |
| Summary: | summary |