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FDA 510(k)

PMT SUBDURAL CORTICAL ELECTRODES

K-Number: K082474 · 2009-05-08

ApplicantPmt Corp.
Decision Date2009-05-08
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PMT SUBDURAL CORTICAL ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Pmt Corp.. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K082474. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMT SUBDURAL CORTICAL ELECTRODES?

PMT SUBDURAL CORTICAL ELECTRODES is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Pmt Corp.. The 510(k) number is K082474.

When did PMT SUBDURAL CORTICAL ELECTRODES receive FDA 510(k) clearance?

PMT SUBDURAL CORTICAL ELECTRODES received FDA 510(k) clearance on 2009-05-08, under 510(k) number K082474.

Who is the listed applicant for PMT SUBDURAL CORTICAL ELECTRODES?

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

What is the FDA product code for PMT SUBDURAL CORTICAL ELECTRODES?

The FDA product code for PMT SUBDURAL CORTICAL ELECTRODES is GYC.

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Other records listing Pmt Corp. 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.

K122376PMT TRUSCAN SURFACE ELECTRODEK090733PMT HALO SYSTEMK042901ENDOMARK STERILE INDIA INKK033730PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIESK972597PMT NEW BEGINNINGS GELSHAPES & AMENDK970418PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)

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Related Devices (Code: GYC)

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.

K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)Neuralynx, Inc.K242618Layer 7-TPrecision Neuroscience, Corp.K221123WISE Cortical Strip (WCS)Wise S.R.L.K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridSpes Medica SrlK201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi MedicalK191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems

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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