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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 a medical device manufactured by Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2016-05-06 under approval 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. It is manufactured by Ad-Tech Medical Instrument Corporation. The 510(k) number is K152769.

When was FREMAP ELECTRODE approved by the FDA?

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

What company makes FREMAP ELECTRODE?

FREMAP ELECTRODE is manufactured by Ad-Tech Medical Instrument Corporation.

What is the FDA product code for FREMAP ELECTRODE?

The FDA product code for FREMAP 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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