Datasea Says VIE Shuhai Jingwei Completed FDA Establishment Registration And Device Listing For NeuroVibe NV-02, NV-03 As Class II 510(k)-Exempt Biofeedback Devices; Says Listing Is Not FDA Approval Or Clearance
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Why It Matters
Datasea's biofeedback devices got listed with the FDA as Class II products, which means they passed a registration step. This shows the company moved forward with its product plans, but remember: listing is not the same as official FDA approval, so there's still more work ahead.
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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
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