FDA 510(k)

JE 2000

K-Number: K993878 · 2000-02-01

Decision Date2000-02-01

Product CodeIKN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

JE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Jack'S Electrodes. It received FDA 510(k) clearance on 2000-02-01 under 510(k) number K993878. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JE 2000?

JE 2000 is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Jack'S Electrodes. The 510(k) number is K993878.

When did JE 2000 receive FDA 510(k) clearance?

JE 2000 received FDA 510(k) clearance on 2000-02-01, under 510(k) number K993878.

Who is the listed applicant for JE 2000?

The FDA 510(k) record lists Jack'S Electrodes as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JE 2000?

The FDA product code for JE 2000 is IKN.

Other records listing Jack'S Electrodes as applicant

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.

K974119DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)

Related Devices (Code: IKN)

K172743Natus VikingQuestNatus Neurology Incorporated K163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLC K123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

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.