OWL UNIVERSAL RF SYSTEM URF-3AP (ML)

Generator, Lesion, Radiofrequency

DIROS TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Universal Rf System Urf-3ap (ml).

Pre-market Notification Details

Device IDK093185
510k NumberK093185
Device Name:OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
ClassificationGenerator, Lesion, Radiofrequency
Applicant DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario,  CA L3r 3k8
ContactGeorge Darmos
CorrespondentGeorge Darmos
DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario,  CA L3r 3k8
Product CodeGXD  
CFR Regulation Number882.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-09
Decision Date2010-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00825114000421 K093185 000
00825114000025 K093185 000
00825114000018 K093185 000

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