Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 With Navigation

Transcranial Magnetic Stimulator

Magstim Company Ltd.

The following data is part of a premarket notification filed by Magstim Company Ltd. with the FDA for Magstim Horizon 3.0 Tms Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 With Navigation.

Pre-market Notification Details

Device IDK211389
510k NumberK211389
Device Name:Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 With Navigation
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 Received2021-05-05
Decision Date2021-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060229532800 K211389 000
05060229532602 K211389 000
05060229532619 K211389 000
05060229532626 K211389 000
05060229532633 K211389 000
05060229532640 K211389 000
05060229532657 K211389 000
05060229532671 K211389 000
05060229532695 K211389 000
05060229532701 K211389 000
05060229532732 K211389 000
05060229532749 K211389 000
05060229532718 K211389 000

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