INSPIRA HD, MODEL: NL1000

System, Tomography, Computed, Emission

NEUROLOGICA CORPORATION

The following data is part of a premarket notification filed by Neurologica Corporation with the FDA for Inspira Hd, Model: Nl1000.

Pre-market Notification Details

Device IDK090811
510k NumberK090811
Device Name:INSPIRA HD, MODEL: NL1000
ClassificationSystem, Tomography, Computed, Emission
Applicant NEUROLOGICA CORPORATION 14 ELECTRONICS AVENUE Danvers,  MA  01923 -1011
ContactDonald D Fickett
CorrespondentDonald D Fickett
NEUROLOGICA CORPORATION 14 ELECTRONICS AVENUE Danvers,  MA  01923 -1011
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-25
Decision Date2009-08-27
Summary:summary

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