ELECTROPHYSIOLOGY CATHETER

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 Electrophysiology Catheter.

Pre-market Notification Details

Device IDK030109
510k NumberK030109
Device Name:ELECTROPHYSIOLOGY CATHETER
ClassificationCatheter, Recording, Electrode, Reprocessed
Applicant ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix,  AZ  85044
ContactMoira Barton
CorrespondentMoira Barton
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 Received2003-01-13
Decision Date2003-08-08
Summary:summary

NIH GUDID Devices

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