Piezon Built-in Kit, Piezon Built-in Kit LED
FDA 510(k) K191079 · E.M.S Electro Medical Systems S.A
510(k) numberK191079
Submission
- Device name
- Piezon Built-in Kit, Piezon Built-in Kit LED
- Applicant
- E.M.S Electro Medical Systems S.A
Nyon, CH - Received
- April 23, 2019
- Decision date
- August 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K182490 | Swiss LithoClast TrilogyFEO · Special | 10/09/2018SE |
| K181997 | Swiss LithoClast TrilogyFEO · Special | 08/30/2018SE |
| K181364 | Swiss LithoClast TrilogyFEO · Special | 06/20/2018SE |
| K173234 | Swiss LithoClast TrilogyFEO · Traditional | 01/10/2018SE |
Questions and answers
When was Piezon Built-in Kit, Piezon Built-in Kit LED cleared by the FDA?
Piezon Built-in Kit, Piezon Built-in Kit LED (K191079) received a 510(k) decision of Substantially Equivalent on August 16, 2019, 115 days after the submission was received.
What is the product code of K191079?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.