MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
FDA 510(k) K163547 · Neurovirtual USA, Inc.
510(k) numberK163547
Submission
- Device name
- MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
- Applicant
- Neurovirtual USA, Inc.
Doral, FL, US - Received
- December 16, 2016
- Decision date
- April 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 cleared by the FDA?
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (K163547) received a 510(k) decision of Substantially Equivalent on April 11, 2017, 116 days after the submission was received.
What is the product code of K163547?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.