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FDA 510(k)

SD LTM STIM Cortical Stimulator

K-Number: K180761 · 2018-06-18

ApplicantMicromed S.P.A.
Decision Date2018-06-18
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SD LTM STIM Cortical Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Micromed S.P.A.. It received FDA 510(k) clearance on 2018-06-18 under 510(k) number K180761. 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 SD LTM STIM Cortical Stimulator?

SD LTM STIM Cortical Stimulator is a medical device that received FDA 510(k) clearance on 2018-06-18. The listed applicant is Micromed S.P.A.. The 510(k) number is K180761.

When did SD LTM STIM Cortical Stimulator receive FDA 510(k) clearance?

SD LTM STIM Cortical Stimulator received FDA 510(k) clearance on 2018-06-18, under 510(k) number K180761.

Who is the listed applicant for SD LTM STIM Cortical Stimulator?

The FDA 510(k) record lists Micromed S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SD LTM STIM Cortical Stimulator?

The FDA product code for SD LTM STIM Cortical Stimulator is GYC.

Other records listing Micromed S.P.A. 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.

K211974LED PHOTIC SystemK171384Micromed BRAIN QUICK system

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

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