DPD-12PCC

Accelerator, Linear, Medical

SCANDITRONIX MEDICAL AB

The following data is part of a premarket notification filed by Scanditronix Medical Ab with the FDA for Dpd-12pcc.

Pre-market Notification Details

Device IDK990734
510k NumberK990734
Device Name:DPD-12PCC
ClassificationAccelerator, Linear, Medical
Applicant SCANDITRONIX MEDICAL AB STALGATAN 14 Uppsala,  SE S-754 50
ContactEva Larsten
CorrespondentEva Larsten
SCANDITRONIX MEDICAL AB STALGATAN 14 Uppsala,  SE S-754 50
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-05
Decision Date1999-05-28
Summary:summary

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