The following data is part of a premarket notification filed by Satelec with the FDA for Sp Newtron Module.
| Device ID | K033764 |
| 510k Number | K033764 |
| Device Name: | SP NEWTRON MODULE |
| Classification | Scaler, Ultrasonic |
| Applicant | SATELEC Z.I. DU PHARE, B.P. 216 17, AVENUE GUSTAVE EIFFEL Merignac Cedex, FR 33708 |
| Contact | Pascal Dupeyron |
| Correspondent | Pascal Dupeyron SATELEC Z.I. DU PHARE, B.P. 216 17, AVENUE GUSTAVE EIFFEL Merignac Cedex, FR 33708 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-02 |
| Decision Date | 2004-03-01 |
| Summary: | summary |