The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Promax, Panoramic X-ray Unit With Cephalostat.
| Device ID | K011619 |
| 510k Number | K011619 |
| Device Name: | PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PLANMECA OY 1250 GREENBRIAR SUITE A Addison, IL 60111 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMECA OY 1250 GREENBRIAR SUITE A Addison, IL 60111 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2001-06-29 |