REPROCESSED 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 Reprocessed Electrophysiology Catheter.

Pre-market Notification Details

Device IDK030279
510k NumberK030279
Device Name:REPROCESSED 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 Received2003-01-27
Decision Date2003-10-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885825011260 K030279 000
00885825011253 K030279 000
00885825011246 K030279 000
00885825011130 K030279 000
00885825011123 K030279 000
00885825011116 K030279 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.