The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Modification To Given Diagnostic System.
| Device ID | K022980 |
| 510k Number | K022980 |
| Device Name: | MODIFICATION TO 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 (shos) Friedman |
| Correspondent | Shoshana (shos) 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 | 2002-09-09 |
| Decision Date | 2003-02-27 |
| Summary: | summary |