IonicRF Generator

Generator, Lesion, Radiofrequency

Abbott Medical

The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ionicrf Generator.

Pre-market Notification Details

Device IDK201610
510k NumberK201610
Device Name:IonicRF Generator
ClassificationGenerator, Lesion, Radiofrequency
Applicant Abbott Medical 5050 Nathan Lane Plymouth,  MN  55442
ContactJim Chapman
CorrespondentJim Chapman
Abbott Medical 5050 Nathan Lane Plymouth,  MN  55442
Product CodeGXD  
CFR Regulation Number882.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2020-10-21

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