The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Rapid Web.
| Device ID | K170839 |
| 510k Number | K170839 |
| Device Name: | RAPID Web |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | Given Imaging Ltd. 2 Hacarmel St New Industrial Park POB 258 Yoqneam, IL 20692 |
| Contact | Hilla Debby |
| Correspondent | Hilla Debby Given Imaging Ltd. 2 Hacarmel St New Industrial Park POB 258 Yoqneam, IL 20692 |
| Product Code | NEZ |
| Subsequent Product Code | NSI |
| Subsequent Product Code | PGD |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-21 |
| Decision Date | 2017-05-26 |
| Summary: | summary |