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FDA 510(k)

EM3 AEM MONITOR AEM CONNECTORS

K-Number: K122383 · 2013-01-10

ApplicantEncision, Inc.
Decision Date2013-01-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EM3 AEM MONITOR AEM CONNECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Encision, Inc.. It received FDA 510(k) clearance on 2013-01-10 under 510(k) number K122383. 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 EM3 AEM MONITOR AEM CONNECTORS?

EM3 AEM MONITOR AEM CONNECTORS is a medical device that received FDA 510(k) clearance on 2013-01-10. The listed applicant is Encision, Inc.. The 510(k) number is K122383.

When did EM3 AEM MONITOR AEM CONNECTORS receive FDA 510(k) clearance?

EM3 AEM MONITOR AEM CONNECTORS received FDA 510(k) clearance on 2013-01-10, under 510(k) number K122383.

Who is the listed applicant for EM3 AEM MONITOR AEM CONNECTORS?

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 EM3 AEM MONITOR AEM CONNECTORS?

The FDA product code for EM3 AEM MONITOR AEM CONNECTORS is GEI.

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Other records listing Encision, Inc. as applicant

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K201018Encision AEM enTouch 2X ScissorK131949AEM DISPOSABLE SUCTION IRRIGATION ELECTRODESK122580AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIESK093622AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015K100711SUCTION IRRIGATION ELECTRODES AND ADAPTERSK091074AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES

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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.

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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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