FDA 510(k)

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015

K-Number: K093622 · 2010-08-20

Decision Date2010-08-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 is the device name listed in this FDA 510(k) record. The listed applicant is Encision, Inc.. It received FDA 510(k) clearance on 2010-08-20 under 510(k) number K093622. 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 MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015?

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 is a medical device that received FDA 510(k) clearance on 2010-08-20. The listed applicant is Encision, Inc.. The 510(k) number is K093622.

When did AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 receive FDA 510(k) clearance?

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 received FDA 510(k) clearance on 2010-08-20, under 510(k) number K093622.

Who is the listed applicant for AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015?

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 MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015?

The FDA product code for AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 is GEI.

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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.