Magnus Neuromodulation System (MNS) With SAINT Technology, Model Number 1001K

Transcranial Magnetic Stimulator

Magnus Medical, Inc.

The following data is part of a premarket notification filed by Magnus Medical, Inc. with the FDA for Magnus Neuromodulation System (mns) With Saint Technology, Model Number 1001k.

Pre-market Notification Details

Device IDK220177
510k NumberK220177
Device Name:Magnus Neuromodulation System (MNS) With SAINT Technology, Model Number 1001K
ClassificationTranscranial Magnetic Stimulator
Applicant Magnus Medical, Inc. 1350 Old Bayshore Highway Suite 600 Burlingame,  CA  94010
ContactBrett Wingeier
CorrespondentSusan Noreiga
Magnus Medical, Inc. 1350 Old Bayshore Highway Suite 600 Burlingame,  CA  94010
Product CodeOBP  
Subsequent Product CodeGWF
Subsequent Product CodeHAW
CFR Regulation Number882.5805 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-21
Decision Date2022-09-01

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