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FDA 510(k)

MODIFICATION TO NC-STAT

K-Number: K041320 · 2004-08-12

ApplicantNeurometrix, Inc.
Decision Date2004-08-12
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO NC-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K041320. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO NC-STAT?

MODIFICATION TO NC-STAT is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Neurometrix, Inc.. The 510(k) number is K041320.

When did MODIFICATION TO NC-STAT receive FDA 510(k) clearance?

MODIFICATION TO NC-STAT received FDA 510(k) clearance on 2004-08-12, under 510(k) number K041320.

Who is the listed applicant for MODIFICATION TO NC-STAT?

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

What is the FDA product code for MODIFICATION TO NC-STAT?

The FDA product code for MODIFICATION TO NC-STAT is JXE.

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Other records listing Neurometrix, Inc. 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.

K152954QuellK130919SENSUSK121816SENSUS ELECTRODEK121184SENSUSK091155ASCENDK083322NEUROMETRIX BIOAMPLIFIER

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Related Devices (Code: JXE)

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.

K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,K190536Mediracer NCSMediracer OYK070109NEUROMETRIX ADVANCENeurometrix, Inc.K060584NC-STATNeurometrix, Inc.K053058XLTEK NEUROPATH, MODEL PK1070Excel Tech. , Ltd.K052904VIRTUAL MEDICAL SYSTEMS MODEL VT3000Scientific Imaging, Inc.

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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