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FDA 510(k)

NEUROTHERM, MODEL JK4

K-Number: K011387 · 2001-09-06

ApplicantEurolink, LLC
Decision Date2001-09-06
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROTHERM, MODEL JK4 is the device name listed in this FDA 510(k) record. The listed applicant is Eurolink, LLC. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K011387. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROTHERM, MODEL JK4?

NEUROTHERM, MODEL JK4 is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Eurolink, LLC. The 510(k) number is K011387.

When did NEUROTHERM, MODEL JK4 receive FDA 510(k) clearance?

NEUROTHERM, MODEL JK4 received FDA 510(k) clearance on 2001-09-06, under 510(k) number K011387.

Who is the listed applicant for NEUROTHERM, MODEL JK4?

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

What is the FDA product code for NEUROTHERM, MODEL JK4?

The FDA product code for NEUROTHERM, MODEL JK4 is GXI.

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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.

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