MLCI2

Accelerator, Linear, Medical

ELEKTA LTD.

The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Mlci2.

Pre-market Notification Details

Device IDK082122
510k NumberK082122
Device Name:MLCI2
ClassificationAccelerator, Linear, Medical
Applicant ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex,  GB Rh10 9rr
ContactPatrick T Hull
CorrespondentPatrick T Hull
ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex,  GB Rh10 9rr
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-28
Decision Date2008-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060191071024 K082122 000

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