Neuro Omega System; NeuroSmart System
FDA 510(k) K250601 · Alpha Omega Engineering , Ltd.
510(k) numberK250601
Submission
- Device name
- Neuro Omega System; NeuroSmart System
- Applicant
- Alpha Omega Engineering , Ltd.
Nof Hagalil (Nazareth Illit), IL - Received
- February 28, 2025
- Decision date
- March 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K220553 | Neuro Omega System, NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 09/16/2022SE |
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More from Neuroone Medical Technologies Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K220553 | Neuro Omega System, NeuroSmart SystemGZL · Special | 09/16/2022SE |
| K191739 | Sterile LeadConfirmGZL · Traditional | 01/02/2020SE |
| K172042 | NeuroNav System, NeuroSmart SystemGZL · Traditional | 02/27/2018SE |
| K171581 | Neuro Omega SystemGZL · Traditional | 12/22/2017SE |
| K123796 | Neuro Omega SystemGZL · Traditional | 04/05/2013SE |
| K120098 | Sterile Disposables for MerGZL · Traditional | 06/12/2012SE |
| K052527 | NeuroprobesGZL · Traditional | 04/12/2006SE |
| K813333 | Alphatemp Clinical ThermometerFLL · Traditional | 12/31/1981SE |
Questions and answers
When was Neuro Omega System; NeuroSmart System cleared by the FDA?
Neuro Omega System; NeuroSmart System (K250601) received a 510(k) decision of Substantially Equivalent on March 30, 2025, 30 days after the submission was received.
What is the product code of K250601?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.