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FDA 510(k)

ELEC Master, ELEC Master Dual

K-Number: K202963 · 2023-05-05

ApplicantMgnewton , Ltd.
Decision Date2023-05-05
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEC Master, ELEC Master Dual is the device name listed in this FDA 510(k) record. The listed applicant is Mgnewton , Ltd.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K202963. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEC Master, ELEC Master Dual?

ELEC Master, ELEC Master Dual is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Mgnewton , Ltd.. The 510(k) number is K202963.

When did ELEC Master, ELEC Master Dual receive FDA 510(k) clearance?

ELEC Master, ELEC Master Dual received FDA 510(k) clearance on 2023-05-05, under 510(k) number K202963.

Who is the listed applicant for ELEC Master, ELEC Master Dual?

The FDA 510(k) record lists Mgnewton , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEC Master, ELEC Master Dual?

The FDA product code for ELEC Master, ELEC Master Dual is EIA.

Other records listing Mgnewton , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202965CURA-Temp

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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