The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Romexis.
| Device ID | K140713 |
| 510k Number | K140713 |
| Device Name: | PLANMECA ROMEXIS |
| Classification | System, Image Processing, Radiological |
| Applicant | PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-21 |
| Decision Date | 2014-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035420254 | K140713 | 000 |