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FDA 510(k)

FREMAP ELECTRODE

K-Number: K152769 · 2016-05-06

ApplicantAd-Tech Medical Instrument Corporation
Decision Date2016-05-06
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FREMAP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K152769. 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 FREMAP ELECTRODE?

FREMAP ELECTRODE is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K152769.

When did FREMAP ELECTRODE receive FDA 510(k) clearance?

FREMAP ELECTRODE received FDA 510(k) clearance on 2016-05-06, under 510(k) number K152769.

Who is the listed applicant for FREMAP ELECTRODE?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREMAP ELECTRODE?

The FDA product code for FREMAP ELECTRODE is ETN.

Other records listing Ad-Tech Medical Instrument Corporation as applicant

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Related Devices (Code: 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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