REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS

Catheter, Recording, Electrode, Reprocessed

ALLIANCE MEDICAL CORP.

The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Ep Technologies Electrophysiology Catheters.

Pre-market Notification Details

Device IDK043393
510k NumberK043393
Device Name:REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS
ClassificationCatheter, Recording, Electrode, Reprocessed
Applicant ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix,  AZ  85044
ContactJenn Selvey
CorrespondentJenn Selvey
ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix,  AZ  85044
Product CodeNLH  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-10
Decision Date2005-03-23
Summary:summary

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