EMS Piezon Master Surgery
FDA 510(k) K072146 · E.M.S Electro Medical Systems S.A
510(k) numberK072146
Submission
- Device name
- EMS Piezon Master Surgery
- Applicant
- E.M.S Electro Medical Systems S.A
North Attleboro, MA, US - Received
- August 3, 2007
- Decision date
- December 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K191124 | Swiss LithoClast TrilogyFFK · Special | 05/29/2019SE |
| K182490 | Swiss LithoClast TrilogyFEO · Special | 10/09/2018SE |
| K181997 | Swiss LithoClast TrilogyFEO · Special | 08/30/2018SE |
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Questions and answers
When was EMS Piezon Master Surgery cleared by the FDA?
EMS Piezon Master Surgery (K072146) received a 510(k) decision of Substantially Equivalent on December 18, 2007, 137 days after the submission was received.
What is the product code of K072146?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.