The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Promax With Dec (dynamic Exposure Control).
| Device ID | K051464 |
| 510k Number | K051464 |
| Device Name: | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PLANMECA OY 100 NORTH GARY AVE. SUITE A Roselle, IL 60172 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMECA OY 100 NORTH GARY AVE. SUITE A Roselle, IL 60172 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-03 |
| Decision Date | 2005-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035420452 | K051464 | 000 |
| 06430035420445 | K051464 | 000 |
| 06430035420292 | K051464 | 000 |