The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Manoscan System.
| Device ID | K151086 |
| 510k Number | K151086 |
| Device Name: | ManoScan System |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | GIVEN IMAGING LTD. 2 HACARMEL ST. NEW INDUSTRIAL PARK POB 258 Yoqneam, IL 20962 |
| Contact | Hilla Debby |
| Correspondent | Hilla Debby GIVEN IMAGING LTD. 2 HACARMEL ST. NEW INDUSTRIAL PARK POB 258 Yoqneam, IL 20962 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-22 |
| Decision Date | 2016-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101369059 | K151086 | 000 |
| 07290101363736 | K151086 | 000 |
| 07290101363729 | K151086 | 000 |
| 07290101363712 | K151086 | 000 |
| 07290101363705 | K151086 | 000 |
| 04260167483719 | K151086 | 000 |
| 04260167483597 | K151086 | 000 |
| 04260167482637 | K151086 | 000 |
| 04260167482545 | K151086 | 000 |
| 04260167482538 | K151086 | 000 |
| 04260167482491 | K151086 | 000 |
| 04260167482262 | K151086 | 000 |
| 04260167482248 | K151086 | 000 |
| 04260167482200 | K151086 | 000 |
| 07290110361273 | K151086 | 000 |
| 07290110360368 | K151086 | 000 |
| 07290110360344 | K151086 | 000 |
| 07290101363958 | K151086 | 000 |
| 07290101365402 | K151086 | 000 |
| 07290101365587 | K151086 | 000 |
| 07290101369042 | K151086 | 000 |
| 07290101366973 | K151086 | 000 |
| 07290101366188 | K151086 | 000 |
| 07290101366102 | K151086 | 000 |
| 07290101365945 | K151086 | 000 |
| 07290101365938 | K151086 | 000 |
| 07290101365921 | K151086 | 000 |
| 07290101365914 | K151086 | 000 |
| 07290101365877 | K151086 | 000 |
| 07290101365860 | K151086 | 000 |
| 07290101365785 | K151086 | 000 |
| 07290101365778 | K151086 | 000 |
| 07290101365754 | K151086 | 000 |
| 07290101365679 | K151086 | 000 |
| 07290101365600 | K151086 | 000 |
| 07290101365594 | K151086 | 000 |
| 07290101369578 | K151086 | 000 |