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FDA 510(k)

NEUROPLUS, MODEL A10040, A10041, A10042, A10043

K-Number: K010638 · 2001-05-03

ApplicantVermont Medical, Inc.
Decision Date2001-05-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPLUS, MODEL A10040, A10041, A10042, A10043 is the device name listed in this FDA 510(k) record. The listed applicant is Vermont Medical, Inc.. It received FDA 510(k) clearance on 2001-05-03 under 510(k) number K010638. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROPLUS, MODEL A10040, A10041, A10042, A10043?

NEUROPLUS, MODEL A10040, A10041, A10042, A10043 is a medical device that received FDA 510(k) clearance on 2001-05-03. The listed applicant is Vermont Medical, Inc.. The 510(k) number is K010638.

When did NEUROPLUS, MODEL A10040, A10041, A10042, A10043 receive FDA 510(k) clearance?

NEUROPLUS, MODEL A10040, A10041, A10042, A10043 received FDA 510(k) clearance on 2001-05-03, under 510(k) number K010638.

Who is the listed applicant for NEUROPLUS, MODEL A10040, A10041, A10042, A10043?

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

What is the FDA product code for NEUROPLUS, MODEL A10040, A10041, A10042, A10043?

The FDA product code for NEUROPLUS, MODEL A10040, A10041, A10042, A10043 is GXY.

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Other records listing Vermont Medical, 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.

K030073VERMED A10021 RESTING EKG TAB ELECTRODEK021537MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005K921498VER MED A10011 PNS DUAL ELEMENT ELECTRODEK915831THERMAL PROBE COVERK911687VER-MED A10020 RESTING EKG ELECTRODEK910139VER-MED A10014 RESTING EKG ELECTRODE & A10021

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Related Devices (Code: GXY)

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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