SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3 Short; NWT Can Slim LED Cord G3 Long
FDA 510(k) K233922 · Satelec - Acteon Group
510(k) numberK233922
Submission
- Device name
- SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3 Short; NWT Can Slim LED Cord G3 Long
- Applicant
- Satelec - Acteon Group
Merignac, FR - Received
- December 13, 2023
- Decision date
- March 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3 Short; NWT Can Slim LED Cord G3 Long cleared by the FDA?
SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3 Short; NWT Can Slim LED Cord G3 Long (K233922) received a 510(k) decision of Substantially Equivalent on March 11, 2024, 89 days after the submission was received.
What is the product code of K233922?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.