DOSE 1

Accelerator, Linear, Medical

SCANDITRONIX WELLHOFER NORTH AMERICA

The following data is part of a premarket notification filed by Scanditronix Wellhofer North America with the FDA for Dose 1.

Pre-market Notification Details

Device IDK000209
510k NumberK000209
Device Name:DOSE 1
ClassificationAccelerator, Linear, Medical
Applicant SCANDITRONIX WELLHOFER NORTH AMERICA 3111 STAGE POST DR., SUITE 105 Bartlett,  TN  38133
ContactChuck Lindley
CorrespondentChuck Lindley
SCANDITRONIX WELLHOFER NORTH AMERICA 3111 STAGE POST DR., SUITE 105 Bartlett,  TN  38133
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-24
Decision Date2000-08-18

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