The following data is part of a premarket notification filed by Superdimension, Ltd. with the FDA for Superdimension/bronchus Premium 2.
| Device ID | K062315 |
| 510k Number | K062315 |
| Device Name: | SUPERDIMENSION/BRONCHUS PREMIUM 2 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SUPERDIMENSION, LTD. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers SUPERDIMENSION, LTD. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2006-09-08 |
| Summary: | summary |