Neuroplus, Model A10040, A10041, A10042, A10043

FDA 510(k) K010638 · Vermont Medical, Inc.

Substantially Equivalent

510(k) numberK010638

Submission

Device name
Neuroplus, Model A10040, A10041, A10042, A10043
Applicant
Vermont Medical, Inc.
Bellows Falls, VT, US
Received
March 5, 2001
Decision date
May 3, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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K252439Tutamen Self Adhesive ElectrodesGXY · Traditional Dongguan Tutamen Metalwork Co., Ltd.05/01/2026SE
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More from Bionit Labs Srl

510(k)DeviceDecision
K030073Vermed A10021 Resting EKG Tab ElectrodeDRX · Special 03/28/2003SE
K021537Multipurpose Neuroplus Electrode, Model A10005GXY · Traditional 03/03/2003SE
K921498Ver Med A10011 PNS Dual Element ElectrodeBXM · Traditional 06/09/1993SE
K915831Thermal Probe CoverFMT · Traditional 06/08/1992SE
K911687Ver-Med A10020 Resting EKG ElectrodeDRX · Traditional 10/10/1991SE
K910139Ver-Med A10014 Resting EKG Electrode & A10021DRX · Traditional 08/15/1991SE
K905489Ver-Med A10017 Universal ElectrodeDRX · Traditional 03/21/1991SE
K781430Pregelled Disposable E.K.G. ElectrodeDRX · Traditional 10/31/1978SE

Questions and answers

When was Neuroplus, Model A10040, A10041, A10042, A10043 cleared by the FDA?

Neuroplus, Model A10040, A10041, A10042, A10043 (K010638) received a 510(k) decision of Substantially Equivalent on May 3, 2001, 59 days after the submission was received.

What is the product code of K010638?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.