Compact Piezo P2K, Powercare
FDA 510(k) K102218 · Mectron S.P.A.
510(k) numberK102218
Submission
- Device name
- Compact Piezo P2K, Powercare
- Applicant
- Mectron S.P.A.
Rome, IT - Received
- August 6, 2010
- Decision date
- January 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Compact Piezo P2K, Powercare cleared by the FDA?
Compact Piezo P2K, Powercare (K102218) received a 510(k) decision of Substantially Equivalent on January 24, 2011, 171 days after the submission was received.
What is the product code of K102218?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.