The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Diagnostic System With Pillcam Eso2 Capsule.
| Device ID | K071153 |
| 510k Number | K071153 |
| Device Name: | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE |
| Classification | System, Imaging, Esophageal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. 91 ROCKYSPRING CIRCLE NW Calgary, Alberta, CA T3g 6a1 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman GIVEN IMAGING LTD. 91 ROCKYSPRING CIRCLE NW Calgary, Alberta, CA T3g 6a1 |
| Product Code | NSI |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-25 |
| Decision Date | 2007-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101363200 | K071153 | 000 |