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FDA 510(k)

Nissha Medical Technologies Neutral Electrodes

K-Number: K203494 · 2021-02-23

ApplicantNissha Medical Technologies, Ltd.
Decision Date2021-02-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nissha Medical Technologies Neutral Electrodes is a medical device manufactured by Nissha Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2021-02-23 under approval number K203494. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nissha Medical Technologies Neutral Electrodes?

Nissha Medical Technologies Neutral Electrodes is a medical device that received FDA 510(k) clearance on 2021-02-23. It is manufactured by Nissha Medical Technologies, Ltd.. The 510(k) number is K203494.

When was Nissha Medical Technologies Neutral Electrodes approved by the FDA?

Nissha Medical Technologies Neutral Electrodes received FDA 510(k) clearance on 2021-02-23, under approval number K203494.

What company makes Nissha Medical Technologies Neutral Electrodes?

Nissha Medical Technologies Neutral Electrodes is manufactured by Nissha Medical Technologies, Ltd..

What is the FDA product code for Nissha Medical Technologies Neutral Electrodes?

The FDA product code for Nissha Medical Technologies Neutral Electrodes is GEI.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41860549 FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications. JAMA network open (2026)

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Official Source

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