DIAGNOSOFT HARP

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.

Pre-market Notification Details

Device IDK061368
510k NumberK061368
Device Name:DIAGNOSOFT HARP
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant DIAGNOSOFT, INC. 3461 KENNETH DRIVE Palo Alto,  CA  94303
ContactAmr A Awadallah
CorrespondentAmr A Awadallah
DIAGNOSOFT, INC. 3461 KENNETH DRIVE Palo Alto,  CA  94303
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-16
Decision Date2006-07-28
Summary:summary

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