Arcus Head Fixation Frame

Holder, Head, Neurosurgical (skull Clamp)

MRI Interventions, Inc.

The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Arcus Head Fixation Frame.

Pre-market Notification Details

Device IDK191701
501k NumberK191701
Device Name:Arcus Head Fixation Frame
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant MRI Interventions, Inc. 5 Musick Irvine,  CA  92618
ContactPete Piferi
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 Thirteenth St. NW Washington,  DC  20004
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-25
Decision Date2019-11-15

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