510(k) K081268
K081268 is an FDA 510(k) premarket notification submitted by Micro-Mega Societe Anonyme for the device "SONIC AIR MM1500 + (MID), MODEL 50400014". The FDA issued a decision of Substantially Equivalent on August 10, 2009. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Micro-Mega Societe Anonyme has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2009
- Date Received
- May 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type