The following data is part of a premarket notification filed by Micro-mega Societe Anonyme with the FDA for Sonic Air Mm1500 + (mid), Model 50400014.
| Device ID | K081268 |
| 510k Number | K081268 |
| Device Name: | SONIC AIR MM1500 + (MID), MODEL 50400014 |
| Classification | Scaler, Ultrasonic |
| Applicant | MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
| Contact | Isabelle Bourg |
| Correspondent | Isabelle Bourg MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-05 |
| Decision Date | 2009-08-10 |