MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM — Given Imaging , Ltd. (510(k) K060805)
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM — Given Imaging , Ltd. (510(k) K060805) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM; Applicant: Given Imaging , Ltd.; Clearance track: 510(k).
| Device name | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM |
|---|---|
| Applicant | Given Imaging , Ltd. |
| Clearance track | 510(k) |
| Submission number | K060805 |
| Decision | Substantially Equivalent |
| Decision date | 2006-05-24 |
| Date received | 2006-03-24 |
| Product code | NSI |
| Device class | 2 |
| Medical specialty | Gastroenterology, Urology |
| Applicant location | IL |
| Source | openFDA device |
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