The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Diagnostic System With M2a Eso Capsule.
| Device ID | K041149 |
| 510k Number | K041149 |
| Device Name: | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE |
| Classification | System, Imaging, Esophageal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. 13 HAYETZIRA STREET NEW INDUSTRIAL ZONE Yokneam, IL 20692 |
| Contact | Shosh Friedman |
| Correspondent | Shosh Friedman GIVEN IMAGING LTD. 13 HAYETZIRA STREET NEW INDUSTRIAL ZONE Yokneam, IL 20692 |
| Product Code | NSI |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-10-25 |
| Summary: | summary |