DRX5000

Equipment, Traction, Powered

AXIOM USA. INC

The following data is part of a premarket notification filed by Axiom Usa. Inc with the FDA for Drx5000.

Pre-market Notification Details

Device IDK023160
510k NumberK023160
Device Name:DRX5000
ClassificationEquipment, Traction, Powered
Applicant AXIOM USA. INC 3830 GUNN HWY Tampa,  FL  33624
ContactJim Gibson
CorrespondentJim Gibson
AXIOM USA. INC 3830 GUNN HWY Tampa,  FL  33624
Product CodeITH  
CFR Regulation Number890.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-23
Decision Date2002-12-20
Summary:summary

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