The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Pillcam Platform With Pillcam Sb Capsules.
| Device ID | K101250 |
| 510k Number | K101250 |
| Device Name: | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | GIVEN IMAGING LTD. NEW INDUSTRIAL PARK P.O. BOX 258 Yoqneam, IL 20692 |
| Contact | Tim Thomas |
| Correspondent | Tim Thomas 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 | 2010-05-04 |
| Decision Date | 2011-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101364467 | K101250 | 000 |
| 07290101362128 | K101250 | 000 |
| 07290101361404 | K101250 | 000 |
| 07290101361145 | K101250 | 000 |
| 07290101361046 | K101250 | 000 |
| 07290101361008 | K101250 | 000 |
| 07290101360995 | K101250 | 000 |
| 07290101360612 | K101250 | 000 |
| 07290101360582 | K101250 | 000 |
| 07290101362234 | K101250 | 000 |
| 07290101362265 | K101250 | 000 |
| 07290101362357 | K101250 | 000 |
| 07290101364306 | K101250 | 000 |
| 07290101363231 | K101250 | 000 |
| 07290101363224 | K101250 | 000 |
| 07290101363194 | K101250 | 000 |
| 07290101362845 | K101250 | 000 |
| 07290101362784 | K101250 | 000 |
| 07290101362371 | K101250 | 000 |
| 07290101362364 | K101250 | 000 |
| 07290101360575 | K101250 | 000 |