The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for The Aio Solution 3.0.
| Device ID | K202068 |
| 510k Number | K202068 |
| Device Name: | The AIO Solution 3.0 |
| Classification | Accelerator, Linear, Medical |
| Applicant | Orfit Industries NV 9A, Vosveld Wijnegem, BE 2110 |
| Contact | Eddy Marivoet |
| Correspondent | Ray Kelly Arazy Group Consultants Inc. 3422 Leonardo Ln New Smyrna Beach, FL 32168 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2020-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420028737576 | K202068 | 000 |
| 05420028723463 | K202068 | 000 |
| 05420028723449 | K202068 | 000 |
| 05420028723401 | K202068 | 000 |
| 05420028718193 | K202068 | 000 |
| 05420028717493 | K202068 | 000 |
| 05420028716601 | K202068 | 000 |
| 05420028716168 | K202068 | 000 |
| 05420028711637 | K202068 | 000 |
| 05420028711057 | K202068 | 000 |
| 05420028710913 | K202068 | 000 |
| 05420028710685 | K202068 | 000 |
| 05420028705841 | K202068 | 000 |
| 05420028705681 | K202068 | 000 |
| 05420028705612 | K202068 | 000 |
| 05420028705605 | K202068 | 000 |
| 05420028729397 | K202068 | 000 |
| 05420028729854 | K202068 | 000 |
| 05420028737095 | K202068 | 000 |
| 05420028735336 | K202068 | 000 |
| 05420028733714 | K202068 | 000 |
| 05420028733707 | K202068 | 000 |
| 05420028733691 | K202068 | 000 |
| 05420028733677 | K202068 | 000 |
| 05420028732281 | K202068 | 000 |
| 05420028732274 | K202068 | 000 |
| 05420028732267 | K202068 | 000 |
| 05420028732243 | K202068 | 000 |
| 05420028732236 | K202068 | 000 |
| 05420028730126 | K202068 | 000 |
| 05420028730102 | K202068 | 000 |
| 05420028729892 | K202068 | 000 |
| 05420028729885 | K202068 | 000 |
| 05420028703113 | K202068 | 000 |