Reprocessed Response Diagnostic Electrophysiology Catheter

Catheter, Recording, Electrode, Reprocessed

Innovative Health, LLC.

The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Response Diagnostic Electrophysiology Catheter.

Pre-market Notification Details

Device IDK182488
510k NumberK182488
Device Name:Reprocessed Response Diagnostic Electrophysiology Catheter
ClassificationCatheter, Recording, Electrode, Reprocessed
Applicant Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
ContactAmanda Babcock
CorrespondentAmanda Babcock
Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale,  AZ  85257
Product CodeNLH  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-11
Decision Date2019-02-22
Summary:summary

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