ELEKTA ESARTE FRAME SYSTEM

Neurological Stereotaxic Instrument

ELEKTA INSTRUMENT AB

The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Elekta Esarte Frame System.

Pre-market Notification Details

Device IDK051746
510k NumberK051746
Device Name:ELEKTA ESARTE FRAME SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm,  SE S-103 93
ContactPeter Lowendahl
CorrespondentPeter Lowendahl
ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm,  SE S-103 93
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-29
Decision Date2005-07-25
Summary:summary

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