HORIZON TMS Therapy System

Transcranial Magnetic Stimulator

Magstim Company Ltd.

The following data is part of a premarket notification filed by Magstim Company Ltd. with the FDA for Horizon Tms Therapy System.

Pre-market Notification Details

Device IDK180907
510k NumberK180907
Device Name:HORIZON TMS Therapy System
ClassificationTranscranial Magnetic Stimulator
Applicant Magstim Company Ltd. Spring Gardens Whitland,  GB Sa34 0hr
ContactTom Campbell
CorrespondentTom Campbell
Magstim Company Ltd. Spring Gardens Whitland,  GB Sa34 0hr
Product CodeOBP  
CFR Regulation Number882.5805 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-06
Decision Date2018-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060229532435 K180907 000
05060229532428 K180907 000
05060229532329 K180907 000

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