E-Shield Multi-paried Subdermal Needle Electrodes
FDA 510(k) K142470 · Neuroinvent, Inc.
510(k) numberK142470
Submission
- Device name
- E-Shield Multi-paried Subdermal Needle Electrodes
- Applicant
- Neuroinvent, Inc.
Cupertino, CA, US - Received
- September 3, 2014
- Decision date
- November 5, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K140200 | E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional | Neuroinvent, Inc. | 07/18/2014SE |
| K130220 | MR Conditional Presson ElectrodeGXZ · Traditional | Rhythmlink International, LLC | 07/22/2013SE |
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More from Technomed Europe
| 510(k) | Device | Decision |
|---|---|---|
| K140200 | E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional | 07/18/2014SE |
Questions and answers
When was E-Shield Multi-paried Subdermal Needle Electrodes cleared by the FDA?
E-Shield Multi-paried Subdermal Needle Electrodes (K142470) received a 510(k) decision of Substantially Equivalent on November 5, 2014, 63 days after the submission was received.
What is the product code of K142470?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.