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FDA 510(k)

EARP Nerve Cuff Electrode

K-Number: K230853 · 2023-10-06

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2023-10-06
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EARP Nerve Cuff Electrode is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2023-10-06 under approval number K230853. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EARP Nerve Cuff Electrode?

EARP Nerve Cuff Electrode is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K230853.

When was EARP Nerve Cuff Electrode approved by the FDA?

EARP Nerve Cuff Electrode received FDA 510(k) clearance on 2023-10-06, under approval number K230853.

What company makes EARP Nerve Cuff Electrode?

EARP Nerve Cuff Electrode is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for EARP Nerve Cuff Electrode?

The FDA product code for EARP Nerve Cuff Electrode is ETN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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