DIAGNOSOFT HARP MODEL 2.06

System, Nuclear Magnetic Resonance Imaging

DIAGNOSOFT, INC.

The following data is part of a premarket notification filed by Diagnosoft, Inc. with the FDA for Diagnosoft Harp Model 2.06.

Pre-market Notification Details

Device IDK100352
510k NumberK100352
Device Name:DIAGNOSOFT HARP MODEL 2.06
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant DIAGNOSOFT, INC. 49 PLAIN STREET North Attleboro,  MA  02760
ContactJeffrey Roberts
CorrespondentJeffrey Roberts
DIAGNOSOFT, INC. 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-12
Decision Date2010-03-11
Summary:summary

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