FDA 510(k)

NC-STAT

K-Number: K982359 · 1998-10-02

Decision Date1998-10-02

Product CodeJXE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

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 1998-10-02 under 510(k) number K982359. 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 NC-STAT?

NC-STAT is a medical device that received FDA 510(k) clearance on 1998-10-02. The listed applicant is Neurometrix, Inc.. The 510(k) number is K982359.

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

NC-STAT received FDA 510(k) clearance on 1998-10-02, under 510(k) number K982359.

Who is the listed applicant for 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 NC-STAT?

The FDA product code for NC-STAT is JXE.

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.

K152954Quell K130919SENSUS K121816SENSUS ELECTRODE K121184SENSUS K091155ASCEND K083322NEUROMETRIX BIOAMPLIFIER

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Related Devices (Code: JXE)

K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,K190536Mediracer NCSMediracer OY K070109NEUROMETRIX ADVANCENeurometrix, Inc.K060584NC-STATNeurometrix, Inc.K053058XLTEK NEUROPATH, MODEL PK1070Excel Tech. , Ltd.K052904VIRTUAL MEDICAL SYSTEMS MODEL VT3000Scientific Imaging, 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.