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FDA 510(k)

Disposable General Electrode

K-Number: K152059 · 2016-04-21

Decision Date2016-04-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable General Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing Limited. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152059. 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 Disposable General Electrode?

Disposable General Electrode is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Modern Medical Equipment Manufacturing Limited. The 510(k) number is K152059.

When did Disposable General Electrode receive FDA 510(k) clearance?

Disposable General Electrode received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152059.

Who is the listed applicant for Disposable General Electrode?

The FDA 510(k) record lists Modern Medical Equipment Manufacturing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable General Electrode?

The FDA product code for Disposable General Electrode is GEI.

Other records listing Modern Medical Equipment Manufacturing Limited 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.

View all 7 devices →

Related Devices (Code: GEI)

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.

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.