The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Diagnostic System.
| Device ID | K053639 |
| 510k Number | K053639 |
| Device Name: | GIVEN DIAGNOSTIC SYSTEM |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. NEW INDUSTRIAL PARK P.O. BOX 258 Yoqneam, IL 20692 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman GIVEN IMAGING LTD. NEW INDUSTRIAL PARK P.O. 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 | 2005-12-30 |
| Decision Date | 2006-05-08 |
| Summary: | summary |