FDA 510(k)

AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES

K-Number: K091074 · 2009-08-17

Decision Date2009-08-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Encision, Inc.. It received FDA 510(k) clearance on 2009-08-17 under 510(k) number K091074. 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 AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES?

AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES is a medical device that received FDA 510(k) clearance on 2009-08-17. The listed applicant is Encision, Inc.. The 510(k) number is K091074.

When did AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES receive FDA 510(k) clearance?

AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES received FDA 510(k) clearance on 2009-08-17, under 510(k) number K091074.

Who is the listed applicant for AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES?

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

What is the FDA product code for AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES?

The FDA product code for AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES is GEI.

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Other records listing Encision, Inc. as applicant

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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.