INTEGRITY MODEL 1014284

Accelerator, Linear, Medical

ELEKTA LTD.

The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Integrity Model 1014284.

Pre-market Notification Details

Device IDK102200
510k NumberK102200
Device Name:INTEGRITY MODEL 1014284
ClassificationAccelerator, Linear, Medical
Applicant ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex,  GB Rh10 9rr
ContactAndrew Hedges
CorrespondentAndrew Hedges
ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex,  GB Rh10 9rr
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-04
Decision Date2010-11-04
Summary:summary

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